AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

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 taken daily for the duration of the study. Patients will undergo invasive coronary studies (angiography, optical coherence tomography and intracoronary flow) and platelet function testing at 2 and 12 months post heart transplant. In addition, angiography will be performed at 24 months post heart transplant and thereafter according to institutional protocol. The primary analysis will determine the feasibility of conducting a large multicenter randomized placebo controlled trial by assessing recruitment rates, event rates, treatment crossovers and loss to follow-up. Secondary analyses will include assessing the effect of antiplatelet treatment on angiographic CAV, coronary intimal disease on optical coherence tomography, coronary macrovascular and microvascular function by intracoronary flow measures, and platelet function.

Inclusion criteria

• Heart transplant
• Age ≥18 years
• Able to provide informed consent

Exclusion criteria

• 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.