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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Brooke Army Medical Center
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center Identifier:
First received: July 7, 2010
Last updated: March 7, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Coronary Graft Patency
Drug: clopidogrel
Drug: sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)

Resource links provided by NLM:

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin alone [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of bleeding between the two treatment arms [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Percent change major adverse cardiovascular events (angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: clopidogrel
aspirin and clopidogrel
Drug: clopidogrel
clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months
Other Name: Plavix
Placebo Comparator: sugar pill
aspirin and placebo
Drug: sugar pill
sugar pill and aspirin 81mg by mouth daily for 12 months
Other Name: 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158703

Contact: Ahmad M Slim, MD 210-916-4717
Contact: Norma J Suarez, MN 210-916-0787

United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Ahmad M Slim, MD    210-916-4717   
Contact: Norma J Suarez, MN    210-916-0787      
Sponsors and Collaborators
Ahmad Slim
Bristol-Myers Squibb
Principal Investigator: Ahmad M Slim, MD Brooke Army Medical Center
Study Chair: Rachel Beck, MD Brooke Army Medical Center
Study Chair: William Conner, MD Brooke Army Medical Center
  More Information

No publications provided

Responsible Party: Ahmad Slim, director, cardiovascular research, Brooke Army Medical Center Identifier: NCT01158703     History of Changes
Other Study ID Numbers: C.2009.120
Study First Received: July 7, 2010
Last Updated: March 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
coronary artery bypass graft

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Sensory System Agents
Therapeutic Uses processed this record on April 23, 2015