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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01130246




Registration number
NCT01130246
Ethics application status
Date submitted
19/04/2010
Date registered
25/05/2010
Date last updated
31/10/2012

Titles & IDs
Public title
VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome
Scientific title
VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
Secondary ID [1] 0 0
AN-CVD2233
Universal Trial Number (UTN)
Trial acronym
VISTA-16
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - A-002, varespladib methyl
Treatment: Drugs - Placebo

Experimental: A-002 500 mg - Once daily oral administration

Placebo comparator: Matched Placebo - Once daily oral administration


Treatment: Drugs: A-002, varespladib methyl
A-002 administered once daily in addition to atorvastatin and standard of care

Treatment: Drugs: Placebo
Placebo administered once daily in addition to atorvastatin and standard of care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Objective of the Study
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Secondary Objective of the Study
Timepoint [1] 0 0
2, 4, 8, 16 weeks and 6 months

Eligibility
Key inclusion criteria
1. Men and women =40 years of age
2. Written informed consent from the subject
3. A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI)

Unstable angina is defined as:
* Chest pain symptomatic of ischemia or angina occurring at rest or on minimal exertion with a pattern of increasing frequency or severity, lasting >10 minutes and consistent with myocardial ischemia within 24 hours prior to hospitalization and
* New or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads and
* In addition subjects meeting the above criteria for unstable angina must also have either troponin I, troponin T or CKMB above the LLD but below the 99th percentile of the upper reference limit (URL) and not due to cardioversion or underlying cardiovascular (CHF, cardiomyopathy) or renal disease

NSTEMI is defined as:
* Chest pain symptomatic of ischemia
* No electrocardiogram (ECG) changes, or ST-depression, or T wave changes(i.e., no new Q waves on serial ECGs)and
* Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB isoenzyme > URL

STEMI is defined as:
* Chest pain symptomatic of ischemia
* ST segment elevation and associated T wave changes or ST-segment elevation of at least 2 mm in 2 contiguous leads, either of which persisting for longer than 15 minutes and
* Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB >URL
4. All subjects must have the presence of at least one of the following risk factors:

* Diabetes Mellitus or
* Presence of any 3 of the following characteristics of metabolic syndrome

* Waist circumference >102 cm in males, >88 cm in females
* Serum triglycerides =150 mg/dL (=1.7 mmol/L)
* HDL-C <40 mg/dL (<1 mmol/L) in males, <50 mg/dL (<1.3 mmol/L) in females
* Blood pressure =130/85 mmHg
* Plasma glucose =110 mg/dL (=6.1 mmol/L) or
* history of cerebrovascular disease (stroke or TIA) or
* history of peripheral vascular disease or
* previous CABG or
* previous documented myocardial infarction or
* previous coronary revascularization
5. Subjects must be randomized within =96 hours of hospital admission for the index event, or if already hospitalized, within =96 hours of index event diagnosis
6. Revascularization, if required or planned, must occur prior to randomization
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects enrolled in another experimental (interventional)protocol within the past 30 days prior to Screening.
2. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision or radiation therapy (e.g. chemotherapy)
3. The presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x ULN)
4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
5. The presence of severe renal impairment (creatinine clearance [CrCl] <30 mL/min or creatinine >3 x ULN),nephrotic syndrome, or subjects undergoing dialysis
6. Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] >11% within the last 1 month prior to Screening)
7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or a condom).
8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
9. Subjects living too far from participating center or unable to return for follow-up visits
10. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
12. Acute bacterial, fungal or viral infection
13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) <30
15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
16. Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
17. Subjects with no stenosis or stenosis <50% on angiography, if known
18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)
19. Fasting triglyceride levels of =400 mg/dL (4.5 mmol/L)
20. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid altering drugs
21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP III

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
5189
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Investigator Site 6106 - Canberra
Recruitment hospital [2] 0 0
Investigator Site 6114 - Gosford
Recruitment hospital [3] 0 0
Investigator Site 6120 - Kingswood
Recruitment hospital [4] 0 0
Investigator Site 6113 - Cairns
Recruitment hospital [5] 0 0
Investigator Site 6112 - Douglas
Recruitment hospital [6] 0 0
Investigator Site 6123 - Nambour
Recruitment hospital [7] 0 0
Investigator Site 6111 - Adelaide
Recruitment hospital [8] 0 0
Investigator Site 6124 - Bedford Park
Recruitment hospital [9] 0 0
Investigator Site 6103 - Elizabeth Vale
Recruitment hospital [10] 0 0
Investigator Site 6122 - Hobart
Recruitment hospital [11] 0 0
Investigator Site 6129 - Epping
Recruitment hospital [12] 0 0
Investigator Site 6127 - Heidelberg
Recruitment hospital [13] 0 0
Investigator Site 6125 - Perth
Recruitment hospital [14] 0 0
Investigator Site 6130 - Perth
Recruitment hospital [15] 0 0
Investigator Site 6118 - Brisbane
Recruitment hospital [16] 0 0
Investigator Site 6126 - Geelong
Recruitment hospital [17] 0 0
Investigator Site 6101 - Kogarah
Recruitment hospital [18] 0 0
Investigator Site 6105 - Melbourne
Recruitment hospital [19] 0 0
Investigator Site 6110 - Nedlands
Recruitment hospital [20] 0 0
Investigator Site 6121 - New Lambton
Recruitment hospital [21] 0 0
Investigator Site 6108 - So Australia
Recruitment hospital [22] 0 0
Investigator Site 6119 - South Port
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4560 - Nambour
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3076 - Epping
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment postcode(s) [14] 0 0
- Brisbane
Recruitment postcode(s) [15] 0 0
- Geelong
Recruitment postcode(s) [16] 0 0
NSW2217 - Kogarah
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment postcode(s) [19] 0 0
NSW2305 - New Lambton
Recruitment postcode(s) [20] 0 0
- So Australia
Recruitment postcode(s) [21] 0 0
4215QLD - South Port
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Mississippi
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Montana
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Nebraska
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New Jersey
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New York
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North Carolina
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North Dakota
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Utah
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Virginia
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Wisconsin
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Alberta
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Erfurt
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Goettingen
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Hamburg
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Kassel
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Lubeck
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Mainz
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Munchen
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Nauen
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Regensburg
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Ulm
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Baranya Megye
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Fejer Megye
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Gaal Jozsef
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Zala Megye
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Eger
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Hodmezovasarhely
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Sopron
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India
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Delhi
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Italy
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Cecina
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Italy
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Rome
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Rozzano (MI)
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Gwangju
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Seoul
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Suwon
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CM
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RA
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Amstelveen
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Amsterdam
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Breda
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Leiden
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Rotterdam
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Schiedam
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Sneek
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Tilburg
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Utrecht
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Venlo
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Auckland
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Hamilton
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Wellington
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Bytom
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Stalowa Wola
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Szczecin
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Barnaui
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Ekaterinburg
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Russian Federation
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Irkutsk
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Kursk
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Leningrad
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Moscow
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Murmansk
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Russian Federation
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Novosibirsk
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Russian Federation
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Orenburg
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Russian Federation
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Rostov-on-Don
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Samara
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Saratov
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St. Petersburg
Country [176] 0 0
Russian Federation
State/province [176] 0 0
St.Petersburg
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Russian Federation
State/province [177] 0 0
Tomsk
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Tyumen
Country [179] 0 0
Spain
State/province [179] 0 0
Asturias
Country [180] 0 0
Spain
State/province [180] 0 0
Barcelona
Country [181] 0 0
Spain
State/province [181] 0 0
Madrid
Country [182] 0 0
Spain
State/province [182] 0 0
Murcia
Country [183] 0 0
Spain
State/province [183] 0 0
Navarra
Country [184] 0 0
Spain
State/province [184] 0 0
Pontevedra
Country [185] 0 0
Spain
State/province [185] 0 0
Vizcaya
Country [186] 0 0
Spain
State/province [186] 0 0
Albacete
Country [187] 0 0
Spain
State/province [187] 0 0
Girona
Country [188] 0 0
Spain
State/province [188] 0 0
Huelva
Country [189] 0 0
Spain
State/province [189] 0 0
Leganes
Country [190] 0 0
Spain
State/province [190] 0 0
Lleida
Country [191] 0 0
Spain
State/province [191] 0 0
Malaga
Country [192] 0 0
Spain
State/province [192] 0 0
Reus
Country [193] 0 0
Spain
State/province [193] 0 0
Santa Cruz de Tenerife
Country [194] 0 0
Spain
State/province [194] 0 0
Sevilla
Country [195] 0 0
Spain
State/province [195] 0 0
Utrera
Country [196] 0 0
Spain
State/province [196] 0 0
Valencia
Country [197] 0 0
Ukraine
State/province [197] 0 0
Dnipropetrovsk
Country [198] 0 0
Ukraine
State/province [198] 0 0
Ivano-Frankivsk
Country [199] 0 0
Ukraine
State/province [199] 0 0
Kharkiv
Country [200] 0 0
Ukraine
State/province [200] 0 0
Kiev
Country [201] 0 0
Ukraine
State/province [201] 0 0
Lviv
Country [202] 0 0
Ukraine
State/province [202] 0 0
Odessa
Country [203] 0 0
Ukraine
State/province [203] 0 0
Poltava

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Anthera Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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 not provided in https://clinicaltrials.gov/study/NCT01130246