The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

Atherosclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00776477
• Other study ID #: NCCD20080101
• Status: Recruiting
• Phase: Phase 3
• First received: October 19, 2008
• Last updated: October 20, 2008
• Start date: December 2007

Study information

• Verified date: October 2008
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• clopidogrel and aspirin
clopidogrel 75mg daily and aspirin 100mg daily
• aspirin
aspirin 100mg daily

Locations

Country	Name	City	State
China	Institute of cardiovascular diseases,Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vein graft patency examined by CT scan		three months after surgery	No
Secondary	Incidence of major adverse coronary events Incidence of major bleeding events		two years following surgery	Yes