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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Vein graft patency examined by CT scan [ Time Frame: three months after surgery ]

Secondary Outcome Measures :
  1. Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ]

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

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Responsible Party: shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital
ClinicalTrials.gov Identifier: NCT00776477    
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