Investigating antiplatelet therapy to prevent complications in heart transplant patients

Is this trial a fit for you?

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

Who can join: the full rules

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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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.