The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atherosclerosis	Drug: clopidogrel and aspirin Drug: aspirin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	December 2007
Estimated Primary Completion Date :	December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin Clopidogrel Clopidogrel bisulfate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: clopidogrel and aspirin clopidogrel 75mg daily and aspirin 100mg daily
Active Comparator: 2	Drug: aspirin aspirin 100mg daily

Outcome Measures

Primary Outcome Measures :

Vein graft patency examined by CT scan [ Time Frame: three months after surgery ]

Secondary Outcome Measures :

Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776477

Locations

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China, Beijing
Institute of cardiovascular diseases,Fuwai hospital	Recruiting
Beijing, Beijing, China, 100037
Contact: ge gao, MD 8601088398244 docgaoge@yahoo.com.cn
Principal Investigator: shengshou hu, MD

Sponsors and Collaborators

China National Center for Cardiovascular Diseases

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital
ClinicalTrials.gov Identifier:	NCT00776477 History of Changes
Other Study ID Numbers:	NCCD20080101
First Posted:	October 21, 2008 Key Record Dates
Last Update Posted:	October 21, 2008
Last Verified:	October 2008

Additional relevant MeSH terms:

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Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents	Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents

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