Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

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.
 
ClinicalTrials.gov Identifier: NCT00776477
Recruitment Status : Unknown
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Recruiting
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases

Tracking Information
First Submitted Date  ICMJE October 19, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date October 21, 2008
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Vein graft patency examined by CT scan [ Time Frame: three months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Drug: clopidogrel and aspirin
    clopidogrel 75mg daily and aspirin 100mg daily
  • Drug: aspirin
    aspirin 100mg daily
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: clopidogrel and aspirin
  • Active Comparator: 2
    Intervention: Drug: aspirin
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776477
Other Study ID Numbers  ICMJE NCCD20080101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital
Study Sponsor  ICMJE China National Center for Cardiovascular Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China National Center for Cardiovascular Diseases
Verification Date October 2008

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