The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
clopidogrel and aspirin
aspirin
Sponsored by

About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
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 < 30%
- 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
Sites / Locations
- Institute of cardiovascular diseases,Fuwai hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Vein graft patency examined by CT scan
Secondary Outcome Measures
Incidence of major adverse coronary events Incidence of major bleeding events
Full Information
NCT ID
NCT00776477
First Posted
October 19, 2008
Last Updated
October 20, 2008
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT00776477
Brief Title
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
5. Study Description
Brief Summary
Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel with aspirin can reduce ischemic events and mortality in patients with atherosclerotic disease,therefore the combination of two antiplatelets might be useful to prevent patients received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus aspirin alone in patients after CABG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
clopidogrel and aspirin
Intervention Description
clopidogrel 75mg daily and aspirin 100mg daily
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
aspirin 100mg daily
Primary Outcome Measure Information:
Title
Vein graft patency examined by CT scan
Time Frame
three months after surgery
Secondary Outcome Measure Information:
Title
Incidence of major adverse coronary events Incidence of major bleeding events
Time Frame
two years following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 < 30%
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
Facility Information:
Facility Name
Institute of cardiovascular diseases,Fuwai hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ge gao, MD
Phone
8601088398244
Email
docgaoge@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
shengshou hu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21050973
Citation
Gao G, Zheng Z, Pi Y, Lu B, Lu J, Hu S. Aspirin plus clopidogrel therapy increases early venous graft patency after coronary artery bypass surgery a single-center, randomized, controlled trial. J Am Coll Cardiol. 2010 Nov 9;56(20):1639-43. doi: 10.1016/j.jacc.2010.03.104.
Results Reference
derived
Learn more about this trial
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
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