Investigating antiplatelet therapy to prevent complications in heart transplant patients
Official title: Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
Run by Ottawa Heart Institute Research Corporation · NCT04770012 · Data updated 2026-11-12
This study tests if giving heart transplant patients early treatment with aspirin or clopidogrel can help prevent a common problem where their heart arteries narrow.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 3 sites (Vancouver, British Columbia and 2 other locations) |
| Status | Recruiting |
| Started | June 28, 2021 |
| Main results expected | March 2027 |
| Study ends | March 2029 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT04770012 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone a heart transplant.
✕Probably not a fit
Patients with allergies to aspirin or clopidogrel, or those with certain bleeding disorders, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial focuses on cardiac allograft vasculopathy, a common complication in heart transplant patients that leads to narrowing of the heart arteries. The research team aims to determine if early antiplatelet therapy with aspirin or clopidogrel can prevent the development of this condition. Participants will be randomized to receive either a placebo, aspirin, or clopidogrel for the duration of the study, with evaluations including invasive coronary studies and platelet function testing at various intervals post-transplant. The primary goal is to assess the feasibility of conducting a larger multicenter randomized trial based on recruitment and event rates.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of cardiac allograft vasculopathy in heart transplant patients.
How similar studies have gone: Other studies have explored antiplatelet therapy in similar contexts, but this specific approach is novel and aims to establish feasibility for a larger trial.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
St.Pauls Hospital
Vancouver, British Columbia, Canada Recruiting -
University of Ottawa Heart Institute
Ottawa, Ontario, Canada Recruiting -
Toronto General Hospital UHN
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Sharon Chih — Ottawa Heart Institute Research Corporation
- Study coordinator: Sharon Chih
- Email: schih@ottawaheart.ca
- Phone: 613-696-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.