Using Dabigatran to prevent strokes in patients with atrial fibrillation and mitral stenosis
Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial
This study is testing if Dabigatran can help prevent strokes in people with atrial fibrillation and mitral stenosis better than the traditional blood thinner Warfarin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04045093 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Dabigatran, a non-vitamin K oral anticoagulant, compared to traditional Warfarin therapy in patients with atrial fibrillation and moderate to severe mitral stenosis. The study is a prospective, randomized, open-label trial with blinded end-point adjudication, where participants will be assigned to receive either Dabigatran or Warfarin. The primary and secondary outcomes will include rates of ischemic stroke, systemic embolism, and major bleeding events. This research aims to provide evidence for the use of NOACs in a patient population that has been historically excluded from such studies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with documented atrial fibrillation and moderate to severe mitral stenosis.
Not a fit: Patients with prosthetic valves, active endocarditis, or those requiring anticoagulation for conditions other than atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation option for patients with atrial fibrillation and mitral stenosis, potentially reducing their risk of stroke.
How similar studies have performed: While there is limited evidence for the use of NOACs in this specific patient group, off-label use has been common, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 old or above * 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 Criteria: * Patients with 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 * Patients with history of intracranial, intraocular, spinal, or retroperitoneal bleeding * 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 an atrial fibrillation * Uncontrolled hypertension (systolic blood pressure \>180mmHg and/or diastolic blood pressure \>100mmHg) * Estimated creatinine clearance equal to or less than 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)
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chun Ka Wong, Clinical Assistant Professor — The University of Hong Kong
- Study coordinator: Chun Ka Wong, Clinical Assistant Professor
- Email: wongeck@hku.hk
- Phone: +852-22553597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.