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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
  Purpose

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 Intervention Phase
Atherosclerosis
 Drug: clopidogrel and aspirin
Drug: aspirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • Vein graft patency examined by CT scan [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of major adverse coronary events Incidence of major bleeding events [ Time Frame: two years following surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: clopidogrel and aspirin
clopidogrel 75mg daily and aspirin 100mg daily
Active Comparator: 2 Drug: aspirin
aspirin 100mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776477

Locations
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

No publications provided by China National Center for Cardiovascular Diseases

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

Responsible Party: shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital
ClinicalTrials.gov Identifier: NCT00776477     History of Changes
Other Study ID Numbers: NCCD20080101
Study First Received: October 19, 2008
Last Updated: October 20, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on June 17, 2013