Aspirin and Plavix Following Coronary Artery Bypass Grafting
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | July 2010 |
| End Date: | July 2015 |
| Contact: | Ahmad M Slim, MD |
| Email: | ahmad.slim@us.army.mil |
| Phone: | 210-916-4717 |
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.
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.
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.
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
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