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The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776477
First Posted: October 21, 2008
Last Update Posted: October 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
China National Center for Cardiovascular Diseases
October 19, 2008
October 21, 2008
October 21, 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 ]
Same as current
No Changes Posted
Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ]
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
Intervention Model: Parallel Assignment
Masking: None (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. doi: 10.1016/j.jacc.2010.03.104.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00776477
NCCD20080101
Not Provided
Not Provided
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
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