Placebo: patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment
aspirin: patients randomized to aspirin study group will be dispensed aspirin capsules to be taken daily for the duration of the treatment
Clopidogrel: patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Feasibility: Recruitment rate — 3 years Average recruitment rate of 4.5 patients per month at 3 study sites
Feasibility: CAV event rate — 3 years 2-year CAV event rate of \>8%
Feasibility: Treatment cross over rate — 3 years Crossover from aspirin to placebo \<2%, clopidogrel to placebo \<2%, placebo to aspirin \<4%, placebo to clopidogrel \<1%
Feasibility: Loss to follow up rate — 3 years Loss-to-follow-up \<1%
Feasibility: Compliance to treatment — 3 years Compliance to treatment \>80%
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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