Clinical trial NCT04770012: AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Official title: Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiac Allograft Vasculopathy
Heart Transplant
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-02-25
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:2:1 randomization to placebo-control, aspirin 81 mg daily or clopidogrel 75 mg daily
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Recruitment rate
timeFrame: 3 years
measure: Feasibility: CAV event rate
timeFrame: 3 years
measure: Feasibility: Treatment cross over rate
timeFrame: 3 years
measure: Feasibility: Loss to follow up rate
timeFrame: 3 years
measure: Feasibility: Compliance to treatment
timeFrame: 3 years
Secondary outcomes:
measure: Cardiac allograft vasculopathy
timeFrame: 1 and 2 years post transplant
measure: Coronary intimal disease
timeFrame: 2 months, 1 year post transplant
measure: Coronary endothelial function
timeFrame: 2 months and 1 year post transplant
measure: Coronary macrovascular function
timeFrame: 2 months and 1 year post transplant
measure: Coronary microvascular function
timeFrame: 2 months and 1 year post transplant
measure: Platelet Function
timeFrame: Baseline, 2 months and 1 year post transplant
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St.Pauls Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital UHN
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Sharon Chih
role: PRINCIPAL_INVESTIGATOR
References: