Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease "DECISIVE"


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Voluntary informed consent
- Diagnosis of AF
- Aortic valvular stenosis, aortic valvular regurgitation, mitral valvular stenosis, or mitral valvular regurgitation of moderate or above severity
- Patients must have one of the following:
- Hypertension requiring medical treatment
- Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 mon or ejection fraction <40% documented by echocardiogram
- Age ≥ 65 years
- Diabetes mellitus on treatment
- History of previous stroke, transient ischemic attack, or systemic embolism
- Previous myocardial infarct, peripheral artery disease, or aortic plaque
- Enlarged left atrial size ≥ 40mm documented by echocardiogram

Exclusion Criteria

- An individual involved in planning or conducting this study
- Unable to understand study conduct or study compliance due to dementia, etc.
- Lack of ability to communicate
- Pregnant woman
- Past cardiac valve replacement
- Stroke resulting in severe disabilities within the past 6 months
- Stroke including silent cerebral infarct within the past 2 weeks
- Chronic renal failure with creatinine clearance < 30ml/min
- Active hepatitis (≥2 fold increase in liver enzyme levels, known active hepatitis C, active hepatitis B, active hepatitis A)
- High bleeding risk
- Major surgery within the past 1 month
- Planned surgery or procedure within 3 months
- Intracranial, intraocular, intraspinal, or retroperitoneal bleeding history or atraumatic joint bleeding history
- Digestive tract bleeding within the past 1 year
- Symptomatic or endoscopically confirmed gastric or duodenal ulcer within the past 30 days
- Hematologic abnormalities
- Requiring anticoagulant treatment for any reasons other than AF
- Requiring antithrombotics within 48 hours of start of the study
- Uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
- Recent malignant tumor or 6 months or longer treatment with radiation therapy
- Mean life expectancy ≤3 years
- Contraindication of anticoagulant treatment
- Screening test results as follows
- Platelet count <80,000 cells/mm3
- Hemoglobin level <10g/dL
- Previous experience of major bleeding complications
- Participation in another drug study within 3 months prior to enrollment to this study
- Administration of the study drug within 1 month prior to enrollment to this study