AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Last updated: March 28, 2025
Sponsor: Ottawa Heart Institute Research Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Transplantation

Vascular Diseases

Treatment

Placebo

aspirin

Clopidogrel

Clinical Study ID

NCT04770012
2020-version 1.0
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Heart transplant

  2. Age ≥18 years

  3. Able to provide informed consent

Exclusion

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 ≤30mL/min/1.73 m2 for non-dialysis patients

  11. Unable to undergo coronary angiography due to unsuitable vascular access

  12. Combined solid organ transplantation.

Study Design

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 28, 2021
Estimated Completion Date:
March 31, 2029

Study Description

Heart transplant patients who fulfill selection criteria will undergo baseline clinical evaluation and data collection. Participants will be randomized to either placebo, aspirin or clopidogrel to be taken daily for the duration of the study. Patients will undergo invasive coronary studies (angiography, optical coherence tomography and intracoronary flow) and platelet function testing at 2 and 12 months post heart transplant. In addition, angiography will be performed at 24 months post heart transplant and thereafter according to institutional protocol. The primary analysis will determine the feasibility of conducting a large multicenter randomized placebo controlled trial by assessing recruitment rates, event rates, treatment crossovers and loss to follow-up. Secondary analyses will include assessing the effect of antiplatelet treatment on angiographic CAV, coronary intimal disease on optical coherence tomography, coronary macrovascular and microvascular function by intracoronary flow measures, and platelet function.

Connect with a study center

  • St.Pauls Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • Toronto General Hospital UHN

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.