Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)

Ahmad Slim

Status and phase: Terminated; Phase 4

Conditions: Coronary Graft Patency

Treatments: Drug: Aspirin; Drug: clopidogrel; Drug: sugar pill

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01158703

C.2009.120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

clopidogrel

Active Comparator group

Description:

aspirin and clopidogrel

Treatment:

Drug: clopidogrel

Drug: Aspirin

sugar pill

Placebo Comparator group

Description:

aspirin and placebo

Treatment:

Drug: sugar pill

Drug: Aspirin