Status:
ACTIVE_NOT_RECRUITING
Dabigatran for Mitral Stenosis Atrial Fibrillation
Lead Sponsor:
The University of Hong Kong
Conditions:
Atrial Fibrillation
Mitral Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Atrial fibrillation (AF) is the most common sustained cardiac arrythmia encountered in clinical practice and patients suffer from this are at increased risk of ischemic stroke and systemic thromboembo...
Detailed Description
While the stroke risk amongst AF patients appears heterogeneous, patients with underlying valvular heart diseases, particularly MS, are at very high risk for stroke if left un-anticoagulated. However,...
Eligibility Criteria
Inclusion
- Patients with atrial fibrillation documented with standard 12-lead ECG documented atrial fibrillation on the day of screening or randomization
- Patients with age ≥ 18 years
- Patients with moderate or severe mitral stenosis, i.e. mitral valvular area (MVA) ≤ 2.5cm2
- Patients should be able to provide a written informed consent
- Patients should have all 4 inclusion-criteria fulfilled to be qualified for the study
Exclusion
- Patients with mechanical prosthetic valve, or with active endocarditis
- Patients with planned valvular intervention within 1 year
- Patients with left atrial appendage occlusive device
- Patients with planned AF ablation
- Unexplained anemia (haemoglobin level \< 10g/dL) or thrombocytopenia (platelet count \< 100x10\*9/L)
- Need for anticoagulant therapy of disorders other than atrial fibrillation
- Patients receiving antiplatelet therapy for disorders other than atrial fibrillation
- Uncontrolled hypertension (systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 100mmHg)
- Estimated creatinine clearance ≤ 30mL/min
- Liver dysfunction of Child Pugh stage B or C
- Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- Patients considered unreliable by the investigator or have a life expectancy less than 1 year because of concomitant disease, or has any condition, which in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse)
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04045093
Start Date
October 22 2020
End Date
September 30 2027
Last Update
December 17 2025
Active Locations (1)
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1
The University of Hong Kong / Queen Mary Hospital
Hong Kong, Hong Kong