AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-28

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Allograft Vasculopathy Heart Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2:2:1 randomization to placebo-control, aspirin 81 mg daily or clopidogrel 75 mg daily

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients, clinical care providers and research staff will be blinded to treatment allocation.

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

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

aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

aspirin

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

Intervention Type DRUG

Clopidogrel

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

Intervention Type DRUG

Other Intervention Names

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plavix

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No