Health TrialsbyHealthPanel

AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

ConditionsCardiac Allograft VasculopathyHeart Transplant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Heart transplant

Age ≥18 years

Able to provide informed consent

Disqualifiers

Allergy or known intolerance to aspirin

Allergy or known intolerance to clopidogrel

Intracranial hemorrhage ≤14 days

Bleeding disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

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

  • aspirin

    Drug

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

  • Clopidogrel

    Drug

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

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: clopidogrelActive comparator 1 intervention
Group C: aspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Recruitment rate

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

Time frame
3 years
2

Feasibility: CAV event rate

2-year CAV event rate of \>8%

Time frame
3 years
3

Feasibility: Treatment cross over rate

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

Time frame
3 years
4

Feasibility: Loss to follow up rate

Loss-to-follow-up \<1%

Time frame
3 years

Secondary outcomes

1

Cardiac allograft vasculopathy

Angiographic CAV disease severity according to ISHLT CAV 0-3 grading

Time frame
1 and 2 years post transplant
2

Coronary intimal disease

Coronary intimal volume measured on OCT

Time frame
2 months, 1 year post transplant
3

Coronary endothelial function

Coronary flow reserve measured by intracoronary flow assessment

Time frame
2 months and 1 year post transplant
4

Coronary macrovascular function

Fractional flow reserve measured by intracoronary flow assessment

Time frame
2 months and 1 year post transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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