Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)
|Atherosclerosis||Drug: Clopidogrel 75 mg daily Drug: water pill daily||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
- Vein graft angiographic patency, one year following surgery [ Time Frame: 1 year ]
- 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 ]
|Study Start Date:||May 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 75mg Clopidogrel
75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
Drug: Clopidogrel 75 mg daily
Daily dose of 75 mg Clopidogrel
Placebo Comparator: Placebo
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 water pill (placebo)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228423
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Marc Ruel, MD, MPH||Ottawa Heart Institute Research Corporation|
|Study Director:||Alexander Kulik, MD||Ottawa Heart Institute Research Corporation|
|Study Director:||Michel Le May, MD||Ottawa Heart Institute Research Corporation|
|Study Director:||George A Wells, PhD||Ottawa Heart Institute Research Corporation|
|Study Director:||Thierry G Mesana, MD, PhD||Ottawa Heart Institute Research Corporation|