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

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be observed in this study is intracardiac thrombus. There are no formal primary or secondary clinical efficacy or safety outcomes because it is a pilot study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Ana Nery
• Treatments: Dabigatran; Warfarin

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