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

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Graft Patency
• Intervention / Treatment: Drug: clopidogrel; Drug: Aspirin; Drug: sugar pill

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: clopidogrel; aspirin and clopidogrel	Drug: clopidogrel; clopidogrel 75mg daily by mouth daily for 12 months; Other Names: Plavix; Drug: Aspirin; aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms); Other Names: ASA, acetylsalicylic acid, Ecotrin, Fasprin
PLACEBO_COMPARATOR: sugar pill; aspirin and placebo	Drug: Aspirin; aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms); Other Names: ASA, acetylsalicylic acid, Ecotrin, Fasprin; Drug: sugar pill; sugar pill by mouth daily for 12 months; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone	Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Bleeding Between the Two Treatment Arms		52 weeks
Number of Major Adverse Cardiovascular Events With Combination Therapy	Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone	52 weeks
Number of Angina Events	Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone	52 weeks
Number of Myocardial Infarction Events	Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone	52 weeks
Number of Thrombotic Events	Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone	52 weeks

Collaborators and Investigators

• Sponsor: Ahmad Slim
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Chair: Rachel Beck, MD, Brooke Army Medical Center; Study Chair: William Conner, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (ESTIMATE): July 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 3, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: clopidogrel; coronary artery bypass graft; aspirin; Plavix
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: C.2009.120