Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228423
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2005-09-26
Brief Title:
Trial of Clopidogrel After Surgery for Coronary Artery Disease CASCADE Trial
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Clopidogrel After Surgery for Coronary Artery Disease CASCADE Trial Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASCADE
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None