The Clopidogrel and Aspirin After Surgery for Coronary Ar... | NCT00776477

Studies
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

NCT00776477

Sponsor

China National Center for Cardiovascular Diseases

Status

Unknown status

Last Update Posted

Oct 21, 2008Estimated

Enrollment

300Estimated

Phase

Phase 3

Conditions

Atherosclerosis

Interventions

clopidogrel and aspirin
aspirin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2008Estimated

Completion Date

Not provided

First Submitted Date

Oct 19, 2008

First Submission Date that Met QC Criteria

Oct 20, 2008

First Posted Date

Oct 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2008

Last Update Posted Date

Oct 21, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: clopidogrel and aspirin
2	Active Comparator		Drug: aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clopidogrel and aspirin	Drug	clopidogrel 75mg daily and aspirin 100mg daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vein graft patency examined by CT scan		three months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Incidence of major adverse coronary events Incidence of major bleeding events		two years following surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of cardiovascular diseases,Fuwai hospital	Recruiting	Beijing	Beijing Municipality	100037	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21050973	Derived	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.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds