A Phase 2 interventional study of Clopidogrel 75 mg daily and water pill daily in Atherosclerosis, sponsored by Ottawa Heart Institute Research Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 2, Interventional, and Prevention
The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.
Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.
Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 113 is close to the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
Drug: Clopidogrel 75 mg daily
Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
Drug: water pill daily
Daily dose of 75 mg Clopidogrel
Daily dose of water pill (placebo)
Vein Graft Intimal Area
IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed
Time frame: One year following surgery
Vein Graft Angiographic Patency
Postoperative angiogram 12 months post-CABG
Time frame: One year following surgery
Incidence of Major Adverse Coronary Events Within One Year Following Surgery
Time frame: 1 year
Incidence of Major Bleeding Events Within One Year Following Surgery
Time frame: 1 year
| Milestone | 75mg Clopidogrel | Placebo |
|---|---|---|
| Started | 56 | 57 |
| Completed | 46 | 45 |
| Not completed | 10 | 12 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Withdrawal by subject | 7 | 3 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Physician decision | 0 | 1 |
IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed
| mm | 75mg Clopidogrel | Placebo |
|---|---|---|
| Vein Graft Intimal Area | 4.1 ± 2.0 | 4.5 ± 2.1 |
Postoperative angiogram 12 months post-CABG
| percentage | 75mg Clopidogrel | Placebo |
|---|---|---|
| Vein Graft Angiographic Patency | 94.3 | 93.2 |
| Participants | 75mg Clopidogrel | Placebo |
|---|---|---|
| Incidence of Major Adverse Coronary Events Within One Year Following Surgery | 4 | 5 |
| Participants | 75mg Clopidogrel | Placebo |
|---|---|---|
| Incidence of Major Bleeding Events Within One Year Following Surgery | 1 | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 75mg Clopidogrel | 0/56 (0%) | 4/56 (7.1%) | 3/56 (5.4%) |
| Placebo | 1/57 (1.8%) | 5/57 (8.8%) | 3/57 (5.3%) |
| Event | 75mg Clopidogrel | Placebo |
|---|---|---|
| Myocardial infarctionCardiac disorders | 4/56 | 0/57 |
| Hospitalization for Coronary IschemiaCardiac disorders | 0/56 | 3/57 |
| Cerebrovascular accidentCardiac disorders | 0/56 | 2/57 |
| Event | 75mg Clopidogrel | Placebo |
|---|---|---|
| Minor bleedingGeneral disorders | 3/56 | 3/57 |
| Age, Continuous(years) | 75mg Clopidogrel | Placebo | Total |
|---|---|---|---|
| Mean | 64.9 ± 7.5 | 68.1 ± 7.4 | 66.0 ± 7.4 |
| Sex: Female, Male(Participants) | 75mg Clopidogrel | Placebo | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 51 | 50 | 101 |
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ottawa Heart Institute Research Corporation