AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

NCT04770012 | Recruiting Phase 3 DMC

• 1 other identifier: 2020-version 1.0
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Allograft Vasculopathy; Heart Transplant

Outcome Measures

Primary Outcomes (5)

• Feasibility: Recruitment rate

  Average recruitment rate of 4.5 patients per month at 3 study sites

  3 years

• Feasibility: CAV event rate

  2-year CAV event rate of \>8%

  3 years

• Feasibility: Treatment cross over rate

  Crossover from aspirin to placebo \<2%, clopidogrel to placebo \<2%, placebo to aspirin \<4%, placebo to clopidogrel \<1%

  3 years

• Feasibility: Loss to follow up rate

  Loss-to-follow-up \<1%

  3 years

• Feasibility: Compliance to treatment

  Compliance to treatment \>80%

  3 years

Secondary Outcomes (6)

• Cardiac allograft vasculopathy

  1 and 2 years post transplant

• Coronary intimal disease

  2 months, 1 year post transplant

• Coronary endothelial function

  2 months and 1 year post transplant

• Coronary macrovascular function

  2 months and 1 year post transplant

• Coronary microvascular function

  2 months and 1 year post transplant

Study Arms (3)

placebo

PLACEBO COMPARATOR

Drug: Placebo

clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

aspirin

ACTIVE COMPARATOR

Drug: aspirin

Interventions

Placebo DRUG

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

placebo

aspirin DRUG

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

aspirin

Clopidogrel DRUG

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

Also known as: plavix

clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Ottawa Heart Institute Research Corporation: lead

Study Sites (3)

St.Pauls Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Toronto General Hospital UHN

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sharon Chih

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Chih

CONTACT

613-696-7000; schih@ottawaheart.ca

Heather Ross

CONTACT

heather.ross@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, clinical care providers and research staff will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 25, 2021
• Study Start: June 28, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (3)