NCT04770012

AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Allograft Vasculopathy
• Heart Transplant

Interventions

Type	Name	Description
DRUG	Placebo	patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment
DRUG	aspirin	patients randomized to aspirin study group will be dispensed aspirin capsules to be taken daily for the duration of the treatment
DRUG	Clopidogrel	patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment

Timeline

• Start date: 2021-06-28
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2021-02-25
• Last updated: 2025-04-03

Locations

3 sites across 1 country: Canada