RecruitingPhase 3NCT04770012

AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

135 participants

Start Date

Jun 28, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Heart transplant
  • Age ≥18 years
  • Able to provide informed consent

Exclusion Criteria12

  • Allergy or known intolerance to aspirin
  • Allergy or known intolerance to clopidogrel
  • Intracranial hemorrhage ≤14 days
  • Bleeding disorder
  • Platelet count <50 x 109/L
  • History of aspirin related gastrointestinal bleeding or ulcers
  • Non-cardiac indication for antiplatelet therapy
  • Anticoagulation >3 months
  • Allergy to iodinated contrast
  • Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
  • Unable to undergo coronary angiography due to unsuitable vascular access
  • Combined solid organ transplantation.

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Interventions

DRUGPlacebo

patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment

DRUGaspirin

patients randomized to aspirin study group will be dispensed aspirin capsules to be taken daily for the duration of the treatment

DRUGClopidogrel

patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment


Locations(3)

St.Pauls Hospital

Vancouver, British Columbia, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Toronto General Hospital UHN

Toronto, Ontario, Canada

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NCT04770012


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