The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

• Sponsor: China National Center for Cardiovascular Diseases (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00776477
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: clopidogrel and aspirin; Drug: aspirin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: clopidogrel and aspirin; clopidogrel 75mg daily and aspirin 100mg daily
Active Comparator: 2	Drug: aspirin; aspirin 100mg daily

Outcome Measures

Primary Outcome Measures

1. Vein graft patency examined by CT scan [three months after surgery]

Secondary Outcome Measures

1. Incidence of major adverse coronary events Incidence of major bleeding events [two years following surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of cardiovascular diseases,Fuwai hospital	Beijing	Beijing	China	100037

Sponsors and Collaborators

• China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00776477
• Other Study ID Numbers: NCCD20080101
• First Posted: Oct 21, 2008
• Last Update Posted: Oct 21, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Atherosclerosis; Aspirin; Clopidogrel

Study Results

No Results Posted as of Oct 21, 2008