Status:
RECRUITING
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiac Allograft Vasculopathy
Heart Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Cardiac allograft vasculopathy is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. The research team is in...
Detailed Description
Heart transplant patients who fulfill selection criteria will undergo baseline clinical evaluation and data collection. Participants will be randomized to either placebo, aspirin or clopidogrel to be ...
Eligibility Criteria
Inclusion
- Heart transplant
- Age ≥18 years
- Able to provide informed consent
Exclusion
- Allergy or known intolerance to aspirin
- Allergy or known intolerance to clopidogrel
- Intracranial hemorrhage ≤14 days
- Bleeding disorder
- Platelet count \<50 x 109/L
- History of aspirin related gastrointestinal bleeding or ulcers
- Non-cardiac indication for antiplatelet therapy
- Anticoagulation \>3 months
- Allergy to iodinated contrast
- Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
- Unable to undergo coronary angiography due to unsuitable vascular access
- Combined solid organ transplantation.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04770012
Start Date
June 28 2021
End Date
March 1 2029
Last Update
April 3 2025
Active Locations (3)
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1
St.Pauls Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
3
Toronto General Hospital UHN
Toronto, Ontario, Canada, M5G 2C4