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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03968393




Registration number
NCT03968393
Ethics application status
Date submitted
22/03/2019
Date registered
30/05/2019

Titles & IDs
Public title
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
Scientific title
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial
Secondary ID [1] 0 0
2019-001336-62
Secondary ID [2] 0 0
2019-ASPIREAF
Universal Trial Number (UTN)
Trial acronym
ASPIRE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Atrial Fibrillation 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Non-vitamin K oral anticoagulant (NOAC)

Experimental: Non-vitamin K oral anticoagulant (NOAC) - Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.

No intervention: No anticoagulation - Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.


Treatment: Drugs: Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Non-hemorrhagic stroke or systemic embolism
Timepoint [1] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Primary outcome [2] 0 0
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
Timepoint [2] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [1] 0 0
Incidence of vascular mortality
Timepoint [1] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [2] 0 0
Incidence of non-fatal, non-hemorrhagic stroke
Timepoint [2] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [3] 0 0
Incidence of Myocardial infarction
Timepoint [3] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [4] 0 0
Incidence of peripheral arterial thrombosis
Timepoint [4] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [5] 0 0
Incidence of amputation
Timepoint [5] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [6] 0 0
Incidence of symptomatic venous thromboembolism
Timepoint [6] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [7] 0 0
Incidence of all-cause stroke
Timepoint [7] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcome [8] 0 0
Incidence of all-cause mortality
Timepoint [8] 0 0
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Eligibility
Key inclusion criteria
1. noncardiac surgery in the past 35 days with at least one of the following:

1. an overnight hospital admission after surgery;
2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. =1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. any of the following high-risk criteria:

1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score =3, or an elevated postoperative troponin level;
2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score =2, or an elevated postoperative troponin level; OR
3. age =75 years.
5. provide written informed consent
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl <20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial

Study design
Purpose of the study
Prevention
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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
2270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Bankstown Hospital - Bankstown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [10] 0 0
Wesley & Greenscopes Private Hospitals - Brisbane
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [12] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2305 - Newcastle
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4575 - Birtinya
Recruitment postcode(s) [10] 0 0
4064 - Brisbane
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
4020 - Redcliffe
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
3677 - Wangaratta
Recruitment postcode(s) [15] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Argentina
State/province [3] 0 0
TDF
Country [4] 0 0
Argentina
State/province [4] 0 0
Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
Chivilcoy
Country [6] 0 0
Brazil
State/province [6] 0 0
Cerqueira César
Country [7] 0 0
Brazil
State/province [7] 0 0
Porto Alegre
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Canada
State/province [15] 0 0
Saskatchewan
Country [16] 0 0
Denmark
State/province [16] 0 0
Aarhus
Country [17] 0 0
Denmark
State/province [17] 0 0
Esbjerg
Country [18] 0 0
Denmark
State/province [18] 0 0
Odense
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
India
State/province [20] 0 0
Assam
Country [21] 0 0
India
State/province [21] 0 0
Gujarat
Country [22] 0 0
India
State/province [22] 0 0
Karnataka
Country [23] 0 0
India
State/province [23] 0 0
Kerala
Country [24] 0 0
India
State/province [24] 0 0
Bangalore
Country [25] 0 0
India
State/province [25] 0 0
Bengaluru
Country [26] 0 0
India
State/province [26] 0 0
Pondicherry
Country [27] 0 0
India
State/province [27] 0 0
Pune
Country [28] 0 0
India
State/province [28] 0 0
Thiruvananthapuram
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Italy
State/province [30] 0 0
Alessandria
Country [31] 0 0
Italy
State/province [31] 0 0
Palermo
Country [32] 0 0
Italy
State/province [32] 0 0
Piacenza
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Nepal
State/province [34] 0 0
Lalitpur
Country [35] 0 0
Netherlands
State/province [35] 0 0
's-Hertogenbosch
Country [36] 0 0
Netherlands
State/province [36] 0 0
Alkmaar
Country [37] 0 0
Netherlands
State/province [37] 0 0
Almelo
Country [38] 0 0
Netherlands
State/province [38] 0 0
Amstelveen
Country [39] 0 0
Netherlands
State/province [39] 0 0
Arnhem
Country [40] 0 0
Netherlands
State/province [40] 0 0
Deventer
Country [41] 0 0
Netherlands
State/province [41] 0 0
Ede
Country [42] 0 0
Netherlands
State/province [42] 0 0
Groningen
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rotterdam
Country [44] 0 0
Netherlands
State/province [44] 0 0
Tilburg
Country [45] 0 0
New Zealand
State/province [45] 0 0
Dunedin
Country [46] 0 0
New Zealand
State/province [46] 0 0
Hamilton
Country [47] 0 0
Pakistan
State/province [47] 0 0
Sindh
Country [48] 0 0
Pakistan
State/province [48] 0 0
Islamabad
Country [49] 0 0
Pakistan
State/province [49] 0 0
Karachi
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Sweden
State/province [52] 0 0
Uppsala
Country [53] 0 0
Switzerland
State/province [53] 0 0
Basel
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Lancashire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hamilton Health Sciences Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
David Conen, MD, MPH
Address 0 0
Population Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cassie McDonald
Address 0 0
Country 0 0
Phone 0 0
1-905-594-0560
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT03968393