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

This study is currently recruiting participants.
Verified March 2014 by Brooke Army Medical Center
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01158703
First received: July 7, 2010
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158703

Contacts
Contact: Ahmad M Slim, MD 210-916-4717 ahmad.slim@us.army.mil
Contact: Norma J Suarez, MN 210-916-0787

Locations
United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Ahmad M Slim, MD    210-916-4717    ahmad.slim@us.army.mil   
Contact: Norma J Suarez, MN    210-916-0787      
Sponsors and Collaborators
Ahmad Slim
Bristol-Myers Squibb
Investigators
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
ClinicalTrials.gov 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:
aspirin
clopidogrel
coronary artery bypass graft
Plavix

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

ClinicalTrials.gov processed this record on April 22, 2014