NCT04770012 AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
| NCT ID | NCT04770012 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Cardiac Allograft Vasculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2021-06-28 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 135 participants in total. It began in 2021-06-28 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Sharon Chih
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT04770012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Allograft Vasculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04770012 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 135 participants.
Is NCT04770012 currently recruiting?
Yes, NCT04770012 is actively recruiting participants. Contact the research team at schih@ottawaheart.ca for enrollment information.
Where is the NCT04770012 trial being conducted?
This trial is being conducted at Vancouver, Canada, Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT04770012 clinical trial?
NCT04770012 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Sharon Chih at Ottawa Heart Institute Research Corporation. The trial plans to enroll 135 participants.