Aspirin and Plavix Following Coronary Artery Bypass Grafting

NCT ID: NCT01158703

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-12-31

Brief Summary

The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.

Detailed Description

The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food & Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery.

After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open.

Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.

Conditions

Coronary Graft Patency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

clopidogrel

aspirin and clopidogrel

Group Type: ACTIVE_COMPARATOR

clopidogrel

Intervention Type: DRUG

clopidogrel 75mg daily by mouth daily for 12 months

Aspirin

Intervention Type: DRUG

aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)

sugar pill

aspirin and placebo

Group Type: PLACEBO_COMPARATOR

sugar pill

Intervention Type: DRUG

sugar pill by mouth daily for 12 months

Aspirin

Intervention Type: DRUG

aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)

Interventions

clopidogrel

clopidogrel 75mg daily by mouth daily for 12 months

Intervention Type: DRUG

sugar pill

sugar pill by mouth daily for 12 months

Intervention Type: DRUG

Aspirin

aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)

Intervention Type: DRUG

Other Intervention Names

Plavix; placebo; ASA, acetylsalicylic acid, Ecotrin, Fasprin

Eligibility Criteria

Inclusion Criteria

• Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass
• Age ≥ 18

Exclusion Criteria

• Left ventricle ejection fraction <30%
• Emergency surgery
• Valve surgery
• Redo CABG
• Postoperative cardiogenic shock for more than 48 hours
• Postoperative bleeding or cardiac tamponade
• More than 24 hours postoperative intubation course
• Requirement of postoperative anticoagulation
• Serum creatinine >1.4
• Contraindication to use of postoperative coronary CT scan
• Allergy or contraindication to aspirin or clopidogrel
• Inability to provide informed consent
• Pregnant or breast feeding females

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Ahmad Slim

FED

Sponsor Role: lead

Responsible Party

Ahmad Slim

director, cardiovascular research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmad M Slim, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Rachel Beck, MD

Role: STUDY_CHAIR

Brooke Army Medical Center

William Conner, MD

Role: STUDY_CHAIR

Brooke Army Medical Center

Locations

Brooke Army Medical Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

C.2009.120

Identifier Type: -

Identifier Source: org_study_id