Investigating antiplatelet therapy to prevent complications in heart transplant patients
Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
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 |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 3 sites (Vancouver, British Columbia and 2 other locations) |
| Trial ID | NCT04770012 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone a heart transplant.
Not a fit: Patients with allergies to aspirin or clopidogrel, or those with certain bleeding disorders, may not benefit from this study.
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 performed: Other studies have explored antiplatelet therapy in similar contexts, but this specific approach is novel and aims to establish feasibility for a larger trial.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.