AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

University of Ottawa Heart Institute

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Allograft Vasculopathy; Heart Transplant

Treatments: Drug: Clopidogrel; Drug: Placebo; Drug: aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04770012

2020-version 1.0

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Heart transplant
2. Age ≥18 years
3. Able to provide informed consent

Exclusion criteria

1. Allergy or known intolerance to aspirin
2. Allergy or known intolerance to clopidogrel
3. Intracranial hemorrhage ≤14 days
4. Bleeding disorder
5. Platelet count <50 x 109/L
6. History of aspirin related gastrointestinal bleeding or ulcers
7. Non-cardiac indication for antiplatelet therapy
8. Anticoagulation >3 months
9. Allergy to iodinated contrast
10. Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
11. Unable to undergo coronary angiography due to unsuitable vascular access
12. Combined solid organ transplantation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

135 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

clopidogrel

Active Comparator group

Treatment:

Drug: Clopidogrel

aspirin

Active Comparator group

Treatment:

Drug: aspirin