Status:
TERMINATED
Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively
Lead Sponsor:
Hospital Ana Nery
Conditions:
Primary Disease
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age from 18 to 64 years at entry
- Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
- 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
- Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
- Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening
- Written, informed consent
Exclusion
- Previous hemorrhagic stroke
- Ischemic stroke in the last 6 months
- Severe renal impairment (creatinine clearance rates \< 30 ml/min)
- Active liver disease (any etiology)
- Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc)
- Increased risk of bleeding (congenital or acquired)
- Uncontrolled hypertension
- Gastrointestinal hemorrhage within the past year
- Anemia (hemoglobin level \<10 g/dL) or thrombocytopenia (platelet count \< 100 × 109/L)
- Active infective endocarditis
- Pregnant or lactating women
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01868243
Start Date
August 1 2013
End Date
October 1 2014
Last Update
October 9 2015
Active Locations (1)
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1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 40320010