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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
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

July 7, 2010
March 7, 2014
July 2010
July 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01158703 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of TIMI major and minor risk 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 ]
Not Provided
Not Provided
 
Aspirin and Plavix Following Coronary Artery Bypass Grafting
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Graft Patency
  • Drug: clopidogrel
    clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months
    Other Name: Plavix
  • Drug: sugar pill
    sugar pill and aspirin 81mg by mouth daily for 12 months
    Other Name: placebo
  • Active Comparator: clopidogrel
    aspirin and clopidogrel
    Intervention: Drug: clopidogrel
  • Placebo Comparator: sugar pill
    aspirin and placebo
    Intervention: Drug: sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Ahmad M Slim, MD 210-916-4717 ahmad.slim@us.army.mil
Contact: Norma J Suarez, MN 210-916-0787
United States
 
NCT01158703
C.2009.120
Yes
Ahmad Slim, Brooke Army Medical Center
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
Brooke Army Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP