Angina and CAD (Coronary Artery Disease)
- The study will research the safety of aspirin plus 3 months of a second blood thinner (antiplatelet) medication [clopidogrel (Plavix), or prasugrel (Effient), or ticagrelor (Brilinta)] in people who have a SYNERGY stent and are high risk for bleeding.
- The coronary stenting procedure that will be performed and the SYNERGY stent you will receive are not investigational.
- The length of time that you may be prescribed by your doctor to take one of these medications (3 months) is investigational. However, recently issued revised guidelines (2016) suggest that stopping dual antiplatelet therapy (DAPT) after 3 months may be reasonable for subjects at high risk for bleeding, following treatment with drug-eluting stents.
CRITERIA LIST/ QUALIFICATIONS:
- Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
- ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit
- Need for chronic or lifelong anticoagulation therapy,
- History of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
- history of stroke (ischemic or hemorrhagic),
- renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
- platelet count ≤100,000/μL
- Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days.
- Subject must be able to take study required antiplatelet therapy.
Ivan Chavez, MD
Boston Scientific Corporation