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The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

NCT ID: NCT00776477

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

clopidogrel and aspirin

Intervention Type DRUG

clopidogrel 75mg daily and aspirin 100mg daily

2

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

aspirin 100mg daily

Interventions

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clopidogrel and aspirin

clopidogrel 75mg daily and aspirin 100mg daily

Intervention Type DRUG

aspirin

aspirin 100mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Institute of cardiovascular diseases& Fuwai Hospital

Locations

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Institute of cardiovascular diseases,Fuwai hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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ge gao, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 21050973 (View on PubMed)

Other Identifiers

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NCCD20080101

Identifier Type: -

Identifier Source: org_study_id