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The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT00776477
First received: October 19, 2008
Last updated: October 20, 2008
Last verified: October 2008

October 19, 2008
October 20, 2008
December 2007
December 2008   (final data collection date for primary outcome measure)
Vein graft patency examined by CT scan [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776477 on ClinicalTrials.gov Archive Site
Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis
  • Drug: clopidogrel and aspirin
    clopidogrel 75mg daily and aspirin 100mg daily
  • Drug: aspirin
    aspirin 100mg daily
  • Experimental: 1
    Intervention: Drug: clopidogrel and aspirin
  • Active Comparator: 2
    Intervention: Drug: aspirin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
China
 
NCT00776477
NCCD20080101
Not Provided
shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital
China National Center for Cardiovascular Diseases
Not Provided
Not Provided
China National Center for Cardiovascular Diseases
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP