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The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Recruiting
Information provided by:
China National Center for Cardiovascular Diseases Identifier:
First received: October 19, 2008
Last updated: October 20, 2008
Last verified: October 2008
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

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 ]

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

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00776477

China, Beijing
Institute of cardiovascular diseases,Fuwai hospital Recruiting
Beijing, Beijing, China, 100037
Contact: ge gao, MD    8601088398244   
Principal Investigator: shengshou hu, MD         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: shengshou hu,MD, Institute of cardiovascular diseases& Fuwai Hospital Identifier: NCT00776477     History of Changes
Other Study ID Numbers: NCCD20080101
Study First Received: October 19, 2008
Last Updated: October 20, 2008

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on August 18, 2017