Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01687998
Registration number
NCT01687998
Ethics application status
Date submitted
12/09/2012
Date registered
19/09/2012
Titles & IDs
Public title
A Study of Evacetrapib in High-Risk Vascular Disease
Query!
Scientific title
Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes
Query!
Secondary ID [1]
0
0
I1V-MC-EIAN
Query!
Secondary ID [2]
0
0
11949
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ACCELERATE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Evacetrapib
Treatment: Drugs - Placebo
Experimental: Evacetrapib - Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
Placebo comparator: Placebo - Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
Treatment: Drugs: Evacetrapib
Administered Orally
Treatment: Drugs: Placebo
Administered Orally
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)
Query!
Assessment method [1]
0
0
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Query!
Timepoint [1]
0
0
Baseline to Study Completion (Up to 4 years)
Query!
Secondary outcome [1]
0
0
Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline, 3 Months
Query!
Secondary outcome [2]
0
0
Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
Query!
Assessment method [2]
0
0
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Query!
Timepoint [2]
0
0
Baseline through End of Study (Up to 4 years)
Query!
Secondary outcome [3]
0
0
Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization
Query!
Assessment method [3]
0
0
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Query!
Timepoint [3]
0
0
Baseline through End of Study (Up to 4 years)
Query!
Secondary outcome [4]
0
0
Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
Query!
Assessment method [4]
0
0
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Query!
Timepoint [4]
0
0
Baseline through End of Study (Up to 4 years)
Query!
Secondary outcome [5]
0
0
Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke
Query!
Assessment method [5]
0
0
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Query!
Timepoint [5]
0
0
Baseline through End of Study (Up to 4 years)
Query!
Eligibility
Key inclusion criteria
* Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, =30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
* Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
* Have a screening high-density lipoprotein cholesterol (HDL-C) =80 milligram per deciliter (mg/dL) (=2.1 millimole per liter [mmol/L])
* Have screening triglycerides (TG) =400 mg/dL (=4.5 mmol/L)
* Meet 1 of the following criteria:
* screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]), OR
* if LDL-C is greater than target, the participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
* Female participants who are known to be pregnant or breastfeeding
* Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of birth control during the study
* History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
* Any reading of systolic blood pressure =180 millimeter of mercury (mm Hg) or diastolic blood pressure =110 mm Hg at screening or randomization
* History of hemorrhagic stroke or intracranial hemorrhage
* New York Heart Association class III or IV congestive heart failure
* Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [µmol/L]) at screening
* Clinically active liver disease. Participants are not excluded due to Gilbert's Syndrome or a history of cholelithiasis/cholecystectomy
* History of malignancy within the preceding 3 years prior to screening
* Known malabsorption syndrome with the exception of lactose intolerance
* Participants with a known history of primary or secondary hyperaldosteronism
* Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
* Any clinically significant medical condition that according to the investigator could interfere with participation in the study
* Participants whose life expectancy is anticipated to be less than 4 years
* Unable or unwilling to comply with study requirements, or deemed by the investigator to be unfit for the study
* Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
* Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic administration of drugs on the exclusion list
* Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months
* Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, participants may be screened and enrolled after all such planned procedures are completed.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
12092
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Camperdown
Query!
Recruitment hospital [2]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Query!
Recruitment hospital [3]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Query!
Recruitment hospital [4]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Milton
Query!
Recruitment hospital [5]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Southport
Query!
Recruitment hospital [6]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woodville
Query!
Recruitment hospital [7]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Launceston
Query!
Recruitment hospital [8]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Query!
Recruitment hospital [9]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Geelong
Query!
Recruitment hospital [10]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Query!
Recruitment hospital [11]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Melbourne
Query!
Recruitment hospital [12]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Windsor
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2522 - Wollongong
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4064 - Milton
Query!
Recruitment postcode(s) [5]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [6]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [7]
0
0
7250 - Launceston
Query!
Recruitment postcode(s) [8]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [9]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [10]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [11]
0
0
3162 - Melbourne
Query!
Recruitment postcode(s) [12]
0
0
3183 - Windsor
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maine
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maryland
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Massachusetts
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Michigan
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Minnesota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Missouri
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Montana
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nebraska
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Jersey
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New York
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Ohio
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oklahoma
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oregon
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Pennsylvania
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Rhode Island
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
South Carolina
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
South Dakota
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Tennessee
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Texas
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Utah
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Virginia
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Washington
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
West Virginia
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Wisconsin
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Belgrano
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Buenos Aires
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Coronel Suarez
Query!
Country [43]
0
0
Argentina
Query!
State/province [43]
0
0
Córdoba
Query!
Country [44]
0
0
Argentina
Query!
State/province [44]
0
0
San Luis
Query!
Country [45]
0
0
Argentina
Query!
State/province [45]
0
0
San Miguel De Tucuman
Query!
Country [46]
0
0
Austria
Query!
State/province [46]
0
0
Feldkirch
Query!
Country [47]
0
0
Austria
Query!
State/province [47]
0
0
Graz
Query!
Country [48]
0
0
Austria
Query!
State/province [48]
0
0
Innsbruck
Query!
Country [49]
0
0
Austria
Query!
State/province [49]
0
0
Vienna
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Antwerpen
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Brussels
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Huy
Query!
Country [53]
0
0
Belgium
Query!
State/province [53]
0
0
Merksem
Query!
Country [54]
0
0
Belgium
Query!
State/province [54]
0
0
Tienen
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Fortaleza
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Rio De Janeiro
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
São Paulo
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Gabrovo
Query!
Country [59]
0
0
Bulgaria
Query!
State/province [59]
0
0
Pazardzhik
Query!
Country [60]
0
0
Bulgaria
Query!
State/province [60]
0
0
Pleven
Query!
Country [61]
0
0
Bulgaria
Query!
State/province [61]
0
0
Plovdiv
Query!
Country [62]
0
0
Bulgaria
Query!
State/province [62]
0
0
Smolyan
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Sofia
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
British Columbia
Query!
Country [65]
0
0
Canada
Query!
State/province [65]
0
0
Newfoundland and Labrador
Query!
Country [66]
0
0
Canada
Query!
State/province [66]
0
0
Ontario
Query!
Country [67]
0
0
Canada
Query!
State/province [67]
0
0
Quebec
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Beijing
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Changsha
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Guang Zhou
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Harbin
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Shanghai
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Shenyang
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Cesky Krumlov
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Hodonin
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Marianske Lazne
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Pardubice
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Pisek
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Prague
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Pribram
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Teplice
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Aalborg
Query!
Country [83]
0
0
Denmark
Query!
State/province [83]
0
0
Ballerup
Query!
Country [84]
0
0
Denmark
Query!
State/province [84]
0
0
Copenhagen
Query!
Country [85]
0
0
Denmark
Query!
State/province [85]
0
0
Kobenhavn
Query!
Country [86]
0
0
Denmark
Query!
State/province [86]
0
0
Vejle
Query!
Country [87]
0
0
Estonia
Query!
State/province [87]
0
0
Tallinn
Query!
Country [88]
0
0
Estonia
Query!
State/province [88]
0
0
Viljandi
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Bordeaux
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Dijon
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Le Coudray
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Paris
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Pessac
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Strasbourg
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Toulouse
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Altenburg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Bad Krozingen
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Berlin
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Bielefeld
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Dortmund
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Dresden
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Frankfurt
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Heidelberg
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Kassel
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Mainz
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Mönchengladbach
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Stuttgart
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Tübingen
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Warendorf
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Wiesbaden
Query!
Country [111]
0
0
Hong Kong
Query!
State/province [111]
0
0
Central
Query!
Country [112]
0
0
Hong Kong
Query!
State/province [112]
0
0
Hong Kong
Query!
Country [113]
0
0
Hong Kong
Query!
State/province [113]
0
0
Shatin
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Bekescsaba
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Budapest
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Debrecen
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Esztergom
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Hodmezovasarhely
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Kalocsa
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Komarom
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Oroshaza
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Szekszard
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Zalaegerszeg
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Haifa
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Jerusalem
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Nazareth
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Rehovot
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Safed
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Tel Hashomer
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Tel-Aviv
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Bologna
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Castelfranco Veneto
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Chieti Scalo
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Milano
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Napoli
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Novara
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Parma
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Piacenza
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
San Daniele Del Friuli
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Sessa Aurunca
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Aichi
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Chiba
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Ehime
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Fukuoka
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Gunma
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Hyogo
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Ibaraki
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Ishikawa
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Kanagawa
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Kumamoto
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Kyoto
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Okinawa
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Osaka
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Saitama
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Shizuoka
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Tokushima
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Tokyo
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Yamaguchi
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Anyang
Query!
Country [160]
0
0
Korea, Republic of
Query!
State/province [160]
0
0
Busan
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Chungbuk
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Daejeon
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Gangwon-Do
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Goyang
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Gwangju
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Seoul
Query!
Country [167]
0
0
Lithuania
Query!
State/province [167]
0
0
Kaunas
Query!
Country [168]
0
0
Lithuania
Query!
State/province [168]
0
0
Klaipeda
Query!
Country [169]
0
0
Lithuania
Query!
State/province [169]
0
0
Vilnius
Query!
Country [170]
0
0
Mexico
Query!
State/province [170]
0
0
Aguascalientes
Query!
Country [171]
0
0
Mexico
Query!
State/province [171]
0
0
Chihuahua
Query!
Country [172]
0
0
Mexico
Query!
State/province [172]
0
0
Cul Sinaloa
Query!
Country [173]
0
0
Mexico
Query!
State/province [173]
0
0
Guadalajara
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Huixquilucan
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Mexico City
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Queretaro
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
San Luis Potosi
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Tampico
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Tijuana
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Amersfoort
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Amsterdam
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Beverwijk
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Delft
Query!
Country [184]
0
0
Netherlands
Query!
State/province [184]
0
0
Den Helder
Query!
Country [185]
0
0
Netherlands
Query!
State/province [185]
0
0
Deventer
Query!
Country [186]
0
0
Netherlands
Query!
State/province [186]
0
0
Drachten
Query!
Country [187]
0
0
Netherlands
Query!
State/province [187]
0
0
Heerlen
Query!
Country [188]
0
0
Netherlands
Query!
State/province [188]
0
0
Hilversum
Query!
Country [189]
0
0
Netherlands
Query!
State/province [189]
0
0
Hoogeveen
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Hoorn
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Leiden
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
S-Hertogenbosch
Query!
Country [193]
0
0
Netherlands
Query!
State/province [193]
0
0
Tilburg
Query!
Country [194]
0
0
Netherlands
Query!
State/province [194]
0
0
Venlo
Query!
Country [195]
0
0
Netherlands
Query!
State/province [195]
0
0
Waalwijk
Query!
Country [196]
0
0
Netherlands
Query!
State/province [196]
0
0
Zaandam
Query!
Country [197]
0
0
Netherlands
Query!
State/province [197]
0
0
Zwijndrecht
Query!
Country [198]
0
0
New Zealand
Query!
State/province [198]
0
0
Addington
Query!
Country [199]
0
0
New Zealand
Query!
State/province [199]
0
0
Grafton
Query!
Country [200]
0
0
New Zealand
Query!
State/province [200]
0
0
Hamilton West
Query!
Country [201]
0
0
New Zealand
Query!
State/province [201]
0
0
Newtown
Query!
Country [202]
0
0
New Zealand
Query!
State/province [202]
0
0
Tauranga
Query!
Country [203]
0
0
New Zealand
Query!
State/province [203]
0
0
Westlake
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Bydgoszcz
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Gdansk
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Katowice
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Krakow
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Kutno
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Lodz
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Olawa
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Pulawy
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Skierniewice
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Sobotka
Query!
Country [214]
0
0
Poland
Query!
State/province [214]
0
0
Warsaw
Query!
Country [215]
0
0
Poland
Query!
State/province [215]
0
0
Wroclaw
Query!
Country [216]
0
0
Puerto Rico
Query!
State/province [216]
0
0
Ponce
Query!
Country [217]
0
0
Puerto Rico
Query!
State/province [217]
0
0
San Juan
Query!
Country [218]
0
0
Puerto Rico
Query!
State/province [218]
0
0
Trujillo Alto
Query!
Country [219]
0
0
Romania
Query!
State/province [219]
0
0
Braila
Query!
Country [220]
0
0
Romania
Query!
State/province [220]
0
0
Bucharest
Query!
Country [221]
0
0
Romania
Query!
State/province [221]
0
0
Buzau
Query!
Country [222]
0
0
Romania
Query!
State/province [222]
0
0
Focsani
Query!
Country [223]
0
0
Romania
Query!
State/province [223]
0
0
Oradea
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Arkhangelsk
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Kemerovo
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Moscow
Query!
Country [227]
0
0
Russian Federation
Query!
State/province [227]
0
0
Saint Petersburg
Query!
Country [228]
0
0
Russian Federation
Query!
State/province [228]
0
0
Smolensk
Query!
Country [229]
0
0
Russian Federation
Query!
State/province [229]
0
0
Tomsk
Query!
Country [230]
0
0
Russian Federation
Query!
State/province [230]
0
0
Yaroslavl
Query!
Country [231]
0
0
Slovakia
Query!
State/province [231]
0
0
Bardejov
Query!
Country [232]
0
0
Slovakia
Query!
State/province [232]
0
0
Bratislava
Query!
Country [233]
0
0
Slovakia
Query!
State/province [233]
0
0
Kralovsky Chlmec
Query!
Country [234]
0
0
Slovakia
Query!
State/province [234]
0
0
Nitra
Query!
Country [235]
0
0
Slovakia
Query!
State/province [235]
0
0
Presov
Query!
Country [236]
0
0
Slovakia
Query!
State/province [236]
0
0
Zilina
Query!
Country [237]
0
0
South Africa
Query!
State/province [237]
0
0
Alberton
Query!
Country [238]
0
0
South Africa
Query!
State/province [238]
0
0
Bellville
Query!
Country [239]
0
0
South Africa
Query!
State/province [239]
0
0
Bloemfontein
Query!
Country [240]
0
0
South Africa
Query!
State/province [240]
0
0
Goodwood
Query!
Country [241]
0
0
South Africa
Query!
State/province [241]
0
0
Johannesburg
Query!
Country [242]
0
0
South Africa
Query!
State/province [242]
0
0
Kuilsriver
Query!
Country [243]
0
0
South Africa
Query!
State/province [243]
0
0
Newlands West
Query!
Country [244]
0
0
South Africa
Query!
State/province [244]
0
0
Parktown West
Query!
Country [245]
0
0
South Africa
Query!
State/province [245]
0
0
Worcester
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Ciudad Real
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Cordoba
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
L´Hospitalet De Llobregat
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Madrid
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Málaga
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Palma De Mallorca
Query!
Country [252]
0
0
Spain
Query!
State/province [252]
0
0
Pamplona
Query!
Country [253]
0
0
Sweden
Query!
State/province [253]
0
0
Lund
Query!
Country [254]
0
0
Sweden
Query!
State/province [254]
0
0
Malmö
Query!
Country [255]
0
0
Sweden
Query!
State/province [255]
0
0
Stockholm
Query!
Country [256]
0
0
Sweden
Query!
State/province [256]
0
0
Östersund
Query!
Country [257]
0
0
Switzerland
Query!
State/province [257]
0
0
Lugano
Query!
Country [258]
0
0
Switzerland
Query!
State/province [258]
0
0
Zürich
Query!
Country [259]
0
0
Taiwan
Query!
State/province [259]
0
0
Kaohsiung City
Query!
Country [260]
0
0
Taiwan
Query!
State/province [260]
0
0
Kaohsiung
Query!
Country [261]
0
0
Taiwan
Query!
State/province [261]
0
0
Kuei Shan Hsiang
Query!
Country [262]
0
0
Taiwan
Query!
State/province [262]
0
0
Taichung City
Query!
Country [263]
0
0
Taiwan
Query!
State/province [263]
0
0
Taichung
Query!
Country [264]
0
0
Taiwan
Query!
State/province [264]
0
0
Taipei
Query!
Country [265]
0
0
Turkey
Query!
State/province [265]
0
0
Ankara
Query!
Country [266]
0
0
Turkey
Query!
State/province [266]
0
0
Konya
Query!
Country [267]
0
0
Ukraine
Query!
State/province [267]
0
0
Kyiv
Query!
Country [268]
0
0
Ukraine
Query!
State/province [268]
0
0
Lutsk
Query!
Country [269]
0
0
Ukraine
Query!
State/province [269]
0
0
Poltava
Query!
Country [270]
0
0
United Kingdom
Query!
State/province [270]
0
0
Cornwall
Query!
Country [271]
0
0
United Kingdom
Query!
State/province [271]
0
0
Hertfordshire
Query!
Country [272]
0
0
United Kingdom
Query!
State/province [272]
0
0
Herts
Query!
Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
London
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
Northants
Query!
Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
West Midlands
Query!
Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Bath
Query!
Country [277]
0
0
United Kingdom
Query!
State/province [277]
0
0
Frome
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The Cleveland Clinic
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).
Query!
Trial website
https://clinicaltrials.gov/study/NCT01687998
Query!
Trial related presentations / publications
Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413. Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19. Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22. Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01687998