Recruiting
Phase 3

Antiplatelet Therapy

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT04770012

Conditions

Cardiac Allograft Vasculopathy

Heart Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

aspirin

Clopidogrel

Study Details

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.

Conditions

Cardiac Allograft Vasculopathy

Heart Transplant

Study ID

NCT04770012

Start date

Jun 28, 2021

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: placebo

active comparator: clopidogrel

active comparator: aspirin

Interventions

Placebo

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

aspirin

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

Clopidogrel

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

Primary outcome measure

  • Feasibility: Recruitment rate [ Time Frame: 3 years ]
  • Feasibility: CAV event rate [ Time Frame: 3 years ]
  • Feasibility: Treatment cross over rate [ Time Frame: 3 years ]
  • Feasibility: Loss to follow up rate [ Time Frame: 3 years ]
  • Feasibility: Compliance to treatment [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Sharon Chih

613-696-7000schih@ottawaheart.ca

Heather Ross

heather.ross@uhn.ca

Locations

St.Pauls Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Toronto General Hospital UHN

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-06.