Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| clopidogrel | Active Comparator |
| |
| aspirin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac allograft vasculopathy | Angiographic CAV disease severity according to ISHLT CAV 0-3 grading | 1 and 2 years post transplant |
| Coronary intimal disease | Coronary intimal volume measured on OCT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Chih | Contact | 613-696-7000 | schih@ottawaheart.ca | |
| Heather Ross | Contact | heather.ross@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Chih | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Pauls Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40653611 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
2:2:1 randomization to placebo-control, aspirin 81 mg daily or clopidogrel 75 mg daily
Not provided
Not provided
Patients, clinical care providers and research staff will be blinded to treatment allocation.
| 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 |
|
|
| 2 months, 1 year post transplant |
| Coronary endothelial function | Coronary flow reserve measured by intracoronary flow assessment | 2 months and 1 year post transplant |
| Coronary macrovascular function | Fractional flow reserve measured by intracoronary flow assessment | 2 months and 1 year post transplant |
| Coronary microvascular function | Index of microcirculatory resistance measured by intracoronary flow assessment | 2 months and 1 year post transplant |
| Platelet Function | Assessment of response to antiplatelet therapy using Enzyme-Linked Immunosorbent Assays (ELISA) for thromboxane B2 and Vasodilator Stimulated Phosphoprotein (VASP). | Baseline, 2 months and 1 year post transplant |
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
|
| Toronto General Hospital UHN | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |