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Recruiting NCT04770012

AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Phase III Interventional Cardiac Allograft Vasculopathy Heart Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, aspirin, Clopidogrel.
Who it may be relevant to
Registry conditions: Cardiac Allograft Vasculopathy, Heart Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Cardiac allograft vasculopathy [Time frame: 1 and 2 years post transplant]
  • Coronary intimal disease [Time frame: 2 months, 1 year post transplant]
  • Coronary endothelial function [Time frame: 2 months and 1 year post transplant]
  • Coronary macrovascular function [Time frame: 2 months and 1 year post transplant]
  • Coronary microvascular function [Time frame: 2 months and 1 year post transplant]
  • Platelet Function [Time frame: Baseline, 2 months and 1 year post transplant]

Eligibility criteria

Inclusion criteria

  • Heart transplant
  • Age ≥18 years
  • Able to provide informed consent

Exclusion criteria

  • Allergy or known intolerance to aspirin
  • Allergy or known intolerance to clopidogrel
  • Intracranial hemorrhage ≤14 days
  • Bleeding disorder
  • Platelet count <50 x 109/L
  • History of aspirin related gastrointestinal bleeding or ulcers
  • Non-cardiac indication for antiplatelet therapy
  • Anticoagulation >3 months
  • Allergy to iodinated contrast
  • Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
  • Unable to undergo coronary angiography due to unsuitable vascular access
  • Combined solid organ transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • St.Pauls Hospital — Vancouver
  • University of Ottawa Heart Institute — Ottawa
  • Toronto General Hospital UHN — Toronto

Publications

  • Rheaume M, Aleksova N, Madsen JC, Benichou G. Chronic Rejection Series: Heart Cardiac Allograft Vasculopathy. Transplantation. 2026 Jan 1;110(1):e28-e41. doi: 10.1097/TP.0000000000005453. Epub 2025 Jul 14. PMID 40653611

Identifiers

NCT: NCT04770012 · 2020-version 1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗