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Trial record 2 of 615 for:    ASPIRIN AND clopidogrel

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

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ClinicalTrials.gov Identifier: NCT01158703
Recruitment Status : Terminated (poor recruitment and reduction in CT surgery support)
First Posted : July 8, 2010
Results First Posted : May 19, 2015
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE July 7, 2010
First Posted Date  ICMJE July 8, 2010
Results First Submitted Date  ICMJE February 23, 2015
Results First Posted Date  ICMJE May 19, 2015
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2015)
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone [ Time Frame: 52 weeks ]
Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone [ Time Frame: 52 weeks ]
Change History Complete list of historical versions of study NCT01158703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2015)
  • Incidence of Bleeding Between the Two Treatment Arms [ Time Frame: 52 weeks ]
  • Number of Major Adverse Cardiovascular Events With Combination Therapy [ Time Frame: 52 weeks ]
    Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone
  • Number of Angina Events [ Time Frame: 52 weeks ]
    Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone
  • Number of Myocardial Infarction Events [ Time Frame: 52 weeks ]
    Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone
  • Number of Thrombotic Events [ Time Frame: 52 weeks ]
    Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • Incidence of TIMI major and minor risk of bleeding between the two treatment arms [ Time Frame: 52 weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin and Plavix Following Coronary Artery Bypass Grafting
Official Title  ICMJE Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Graft Patency
Intervention  ICMJE
  • Drug: clopidogrel
    clopidogrel 75mg daily by mouth daily for 12 months
    Other Name: Plavix
  • Drug: sugar pill
    sugar pill by mouth daily for 12 months
    Other Name: placebo
  • Drug: Aspirin
    aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)
    Other Name: ASA, acetylsalicylic acid, Ecotrin, Fasprin
Study Arms  ICMJE
  • Active Comparator: clopidogrel
    aspirin and clopidogrel
    Interventions:
    • Drug: clopidogrel
    • Drug: Aspirin
  • Placebo Comparator: sugar pill
    aspirin and placebo
    Interventions:
    • Drug: sugar pill
    • Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 3, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2010)
150
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01158703
Other Study ID Numbers  ICMJE C.2009.120
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmad Slim, Brooke Army Medical Center
Study Sponsor  ICMJE Ahmad Slim
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
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
PRS Account Brooke Army Medical Center
Verification Date May 2015

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