AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
Ottawa Heart Institute Research Corporation
135 participants
Jun 28, 2021
INTERVENTIONAL
Conditions
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 investigating whether early antiplatelet therapy post heart transplant can prevent the development of CAV. This study will determine the feasibility of a large multicenter randomized placebo-controlled trial to answer this question.
Eligibility
Inclusion Criteria3
- Heart transplant
- Age ≥18 years
- Able to provide informed consent
Exclusion Criteria12
- 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.
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Interventions
patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment
patients randomized to aspirin study group will be dispensed aspirin capsules to be taken daily for the duration of the treatment
patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04770012