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AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

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ClinicalTrials.gov Identifier: NCT04770012
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : August 14, 2023
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Cardiac Allograft Vasculopathy Heart Transplant Drug: Placebo Drug: aspirin Drug: Clopidogrel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:2:1 randomization to placebo-control, aspirin 81 mg daily or clopidogrel 75 mg daily
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients, clinical care providers and research staff will be blinded to treatment allocation.
Primary Purpose: Treatment
Official Title: Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo Drug: Placebo
patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment

Active Comparator: clopidogrel Drug: Clopidogrel
patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment
Other Name: plavix

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




Primary Outcome Measures :
  1. Feasibility: Recruitment rate [ Time Frame: 3 years ]
    Average recruitment rate of 4.5 patients per month at 3 study sites

  2. Feasibility: CAV event rate [ Time Frame: 3 years ]
    2-year CAV event rate of >8%

  3. Feasibility: Treatment cross over rate [ Time Frame: 3 years ]
    Crossover from aspirin to placebo <2%, clopidogrel to placebo <2%, placebo to aspirin <4%, placebo to clopidogrel <1%

  4. Feasibility: Loss to follow up rate [ Time Frame: 3 years ]
    Loss-to-follow-up <1%

  5. Feasibility: Compliance to treatment [ Time Frame: 3 years ]
    Compliance to treatment >80%


Secondary Outcome Measures :
  1. Cardiac allograft vasculopathy [ Time Frame: 1 and 2 years post transplant ]
    Angiographic CAV disease severity according to ISHLT CAV 0-3 grading

  2. Coronary intimal disease [ Time Frame: 2 months, 1 year post transplant ]
    Coronary intimal volume measured on OCT

  3. Coronary endothelial function [ Time Frame: 2 months and 1 year post transplant ]
    Coronary flow reserve measured by intracoronary flow assessment

  4. Coronary macrovascular function [ Time Frame: 2 months and 1 year post transplant ]
    Fractional flow reserve measured by intracoronary flow assessment

  5. Coronary microvascular function [ Time Frame: 2 months and 1 year post transplant ]
    Index of microcirculatory resistance measured by intracoronary flow assessment

  6. Platelet Function [ Time Frame: Baseline, 2 months and 1 year post transplant ]
    Assessment of response to antiplatelet therapy using Enzyme-Linked Immunosorbent Assays (ELISA) for thromboxane B2 and Vasodilator Stimulated Phosphoprotein (VASP).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770012


Contacts
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Contact: Sharon Chih 613-696-7000 schih@ottawaheart.ca
Contact: Heather Ross heather.ross@uhn.ca

Locations
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Canada, British Columbia
St.Pauls Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Mustafa Toma         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Sharon Chih         
Toronto General Hospital UHN Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Heather Ross         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Sharon Chih Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04770012    
Other Study ID Numbers: 2020-version 1.0
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents