Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively

Launched by HOSPITAL ANA NERY · Jun 3, 2013

Keywords

ClinConnect Summary

Mortality and morbidity events (reversible ischemic neurological deficit, ischemic and hemorrhagic stroke, systemic embolism, any bleeding, prosthesis valve thrombosis and death) were evaluated in an exploratory manner. The details of the trial design have been previously described.8 The trial protocol was approved by the local ethics and research committee in the city of Salvador-Brazil, and written informed consent was obtained from all patients. An independent data and safety monitoring board closely monitored the trial. All the members contributed to the interpretation of the results, w...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age from 18 to 64 years at entry
• • 2. Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
• • 3. There is 12-lead electrocardiogram documented AF on the day of screening or randomization; or a 24-hour Holter electrocardiogram recording showing AF episodes postoperatively
• • 4. Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
• • 5. Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening
• • 6. Written, informed consent
• Exclusion Criteria:
• • 1. Previous hemorrhagic stroke
• • 2. Ischemic stroke in the last 6 months
• • 3. Severe renal impairment (creatinine clearance rates \< 30 ml/min)
• • 4. Active liver disease (any etiology)
• • 5. Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc)
• • 6. Increased risk of bleeding (congenital or acquired)
• • 7. Uncontrolled hypertension
• • 8. Gastrointestinal hemorrhage within the past year
• • 9. Anemia (hemoglobin level \<10 g/dL) or thrombocytopenia (platelet count \< 100 × 109/L)
• • 10. Active infective endocarditis
• • 11. Pregnant or lactating women