The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 19, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedOctober 21, 2008
October 1, 2008
1 year
October 19, 2008
October 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Vein graft patency examined by CT scan
three months after surgery
Secondary Outcomes (1)
Incidence of major adverse coronary events Incidence of major bleeding events
two years following surgery
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of cardiovascular diseases,Fuwai hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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.
PMID: 21050973DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
October 19, 2008
First Posted
October 21, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Last Updated
October 21, 2008
Record last verified: 2008-10