The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

National Center for Cardiovascular Diseases

Status and phase: Unknown; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: clopidogrel and aspirin; Drug: aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00776477

NCCD20080101

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: clopidogrel and aspirin

2

Active Comparator group

Treatment:

Drug: aspirin