Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis |
Drug: Clopidogrel 75 mg daily |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass? |
- Vein graft intimal area, one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Vein graft angiographic patency, one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence of major adverse coronary events within one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Incidence of major bleeding events within one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 92 |
| Study Start Date: | May 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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Drug: Clopidogrel 75 mg daily
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.
Exclusion Criteria:
- Emergency surgery
- Valve surgery
- Redo CABG
- Left ventricle ejection fraction < 25%
- Serum creatinine > 130 µmol/L
- Preoperative use of clopidogrel (with the exception of the current admission)
- Preoperative use of warfarin; allergy to aspirin or clopidogrel.
- History of cerebrovascular accident
- History of severe liver disease
- Morbid obesity
- Current malignancy
Contacts and Locations| Canada, Ontario | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Principal Investigator: | Marc Ruel, MD, MPH | University of Ottawa Heart Institute |
| Study Director: | Alexander Kulik, MD | University of Ottawa Heart Institute |
| Study Director: | Michel Le May, MD | University of Ottawa Heart Institute |
| Study Director: | George A Wells, PhD | University of Ottawa Heart Institute |
| Study Director: | Thierry G Mesana, MD, PhD | University of Ottawa Heart Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Marc Ruel, MD, University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00228423 History of Changes |
| Other Study ID Numbers: | UOHI 2006-111 |
| Study First Received: | September 26, 2005 |
| Last Updated: | June 25, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Ottawa Heart Institute:
|
Saphenous vein Intimal hyperplasia Coronary artery bypass graft surgery |
Antiplatelet therapy Clopidogrel Saphenous vein graft disease |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013