Overview

Antiplatelet Therapy in Heart Transplantation

Status:
Not yet recruiting
Trial end date:
2024-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborator:
Canadian Institutes of Health Research (CIHR)
Treatments:
Aspirin
Clopidogrel
Criteria
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.