NCT04045093Active, not recruitingPhase 4
Dabigatran for Mitral Stenosis Atrial Fibrillation
Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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 thromboembolism due to the formation and embolism of left atrial thrombi. Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention amongst these patients with non-valvular atrial fibrillation (AF) at significant ischemic stroke risk, given the superior safety and comparable efficacy of NOACs over warfarin. However, the safety and efficacy of NOACs had not been evaluated in AF patients with underlying mitral stenosis (MS) thereby the currently recommended stroke prevention strategy remains warfarin therapy for AF patients with underlying MS. A local study is initiated to compare efficacy and safety of Dabigatran with Warfarin therapy in AF patients with moderate to severe MS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 2 Aug 2019
- Start date
- 22 Oct 2020
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- The University of Hong Kong
- Diseases
- Atrial fibrillation
- NCT number
- NCT04045093
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 370
- From 22 Oct 2020 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving antiplatelet therapy for disorders other than atrial fibrillation
- 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)
Other illness
- Need for anticoagulant therapy of disorders other than atrial fibrillation
- Uncontrolled hypertension (systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 100mmHg)
Lab values
- Unexplained anemia (haemoglobin level \< 10g/dL) or thrombocytopenia (platelet count \< 100x10\*9/L)
- Estimated creatinine clearance ≤ 30mL/min
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong/Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.