Clinical trial NCT01158703: Aspirin and Plavix Following Coronary Artery Bypass Grafting
Official title: Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Graft Patency
Keywords: aspirin
clopidogrel
coronary artery bypass graft
Plavix
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
timeFrame: 52 weeks
Secondary outcomes:
measure: Incidence of Bleeding Between the Two Treatment Arms
timeFrame: 52 weeks
measure: Number of Major Adverse Cardiovascular Events With Combination Therapy
timeFrame: 52 weeks
measure: Number of Angina Events
timeFrame: 52 weeks
measure: Number of Myocardial Infarction Events
timeFrame: 52 weeks
measure: Number of Thrombotic Events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Ahmad M Slim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center
name: Rachel Beck, MD
role: STUDY_CHAIR
affiliation: Brooke Army Medical Center
name: William Conner, MD
role: STUDY_CHAIR
References: