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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2008
Last Updated Date	October 20, 2008
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00776477 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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.
* 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	Recruiting
Estimated Enrollment ^ICMJE	300
Completion Date	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00776477
Other Study ID Numbers ^ICMJE	NCCD20080101
Has Data Monitoring Committee	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
Information Provided By	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

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