- Trial ID:
- Matthew Price
- 1. Adjunctive oral anticoagulation treatment planned to continue after PCI
- 2. Age ≥ 75 years old
- 3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
- 4. Any prior intracerebral bleed
- 5. Any stroke in the last 12 months
- 6. Hospital admission for bleeding during the prior 12 months
- 7. Non skin cancer diagnosed or treated < 3 years, with a perceived increased risk for bleeding
- 8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
- 9. Planned surgery that would require interruption of DAPT (within next 6 months)
- 10. Renal failure defined as: Creatinine clearance <40 ml/min
- 11. Thrombocytopenia (PLT <100,000/mm3)
- 12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- 13. Expected non-compliance to prolonged DAPT for other medical reasons
Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or more of the following:
- 1. Pregnant and breastfeeding women
- 2. Patients expected not to comply with 1 month DAPT
- 3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
- 4. Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
- 5. Active bleeding at the time of inclusion
- 6. Reference vessel diameter <2.25 - >4.0mm
- 7. Cardiogenic shock
- 8. Compliance with long-term single anti-platelet therapy unlikely
- 9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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