Atrial FibrillationPhase 4David-MSNCT04045093
Dabigatran for Mitral Stenosis Atrial Fibrillation
A Phase 4 study testing Dabigatran etexilate and Warfarin in people with Atrial Fibrillation and Mitral Stenosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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 thromboembolism due to the formation and embolism of left atrial thrombi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Mitral Stenosis
- What is being tested?
- Dabigatran etexilate and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Oct 2020to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial
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.
Read the 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, this group of patients was typically excluded in randomized control trials. As a result, current international guidelines for management of AF do not recommend NOACs for stroke prevention in AF patients with underlying moderate or severe MS. Nonetheless off-label use of NOACs in patients with MS is not uncommon in the real world practice.
This is of particular importance for Asian AF patients, in whom MS remains relatively prevalent despite a declining trend. More importantly, the much higher baseline risk of intracranial haemorrhage and apparently higher ischemic stroke risk in Asian populations potentially undermine the benefits of Warfarin therapy. On the other hand, the efficacy and safety of NOACs compared with Warfarin appear to be even higher in Asian population than the non-Asian population as shown in sub-analyses pivotal randomised control trials as well as in the real world evidence. This study refers as a prospective, randomized, open-label trial with blinded end-point adjudication, aiming at evaluating the safety and efficacy of Dabigatran for stroke prevention in AF patients with underlying moderate or severe MS.
After providing written informed consent, study participants from participating local centres will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran (150mg or 110mg according to creatinine clearance level, twice daily) or Warfarin (targeting in the international normalized ratio (INR) range 2-3) in an open-label design. In a year of individual study period, vital signs, laboratory blood check and adverse events will be monitored, and primary and secondary outcomes will be assessed. The estimated sample size is approximately 370 participants. On addition, a subgroup of patients up to 10% of the target sample size will be invited for an one-time non-invasive magnetic resonance imaging (MRI) for assessment of any intra-cardiac thrombus.
The results will be an important contribution to the stroke prevention strategy for patients with MS and may be immediately translatable to real clinical practice. Ultimately, this study will provide the necessary evidence for establishing universal guidelines for this group of patients.
- Conditions
- Atrial Fibrillation, Mitral Stenosis
- Being tested
- Dabigatran etexilate, Warfarin
- Medical subject headings
- Atrial Fibrillation, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
Also called Pradaxa
Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
WarfarinDrug
Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate | Experimental | Subjects randomized into this group will be prescribed with either Dabigatran 150mg or Dabigatran 110mg (twice daily) according to creatinine clearance level) for stroke prevention. Receives: Drug: Dabigatran etexilate |
| Warfarin | Active comparator | Subjects randomized into this group will be prescribed with Warfarin with dosage adjustment according to INR level (targeting to INR 2-3) for stroke prevention. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of stroke, systemic embolism, myocardial infarction, and death from cardiovascular or unknown cause.
Stroke is classified into ischemic or hemorrhagic stroke, as confirmed by computed tomography or magnetic resonance imaging.
Systemic embolism is defined as an acute vascular occlusion of an extremity or organ other than the brain, documented by imaging, surgery, and/or autopsy.
Myocardial infarction is defined according to the latest ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes, with the assessment of electrocardiography, cardiac troponin values and presence of symptoms.
Death is counted when subject is medically certified of death, resulted from cardiovascular or unknown cause.
Measured: 1 year
Secondary outcomes (5)
Ischemic stroke
It is defined as the first episode during follow-up of new-onset of neurological symptoms attributable to a cerebral infarct, as confirmed by computed tomography or magnetic resonance imaging, lasting more than 24 hours.
Measured: 1 year
Hemorrhagic stroke
It is defined as the first episode during follow-up of new-onset of neurological symptoms attributable to an intraparenchymal or subarachnoid hemorrhage, as confirmed by computed tomography or magnetic resonance imaging.
Measured: 1 year
Systemic embolism
It is defined as an acute vascular occlusion of an extremity or organ other than the brain, documented by imaging, surgery, and/or autopsy.
Measured: 1 year
Major bleeding
Bleeding being categorized as BARC type 3 or higher is regarded as major bleeding.
Measured: 1 year
Death
It is counted when subject is medically certified of death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start22 Oct 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study with randomization in 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Chun Ka, The University of Hong Kong
- Investigators
- Siu Han Jo Jo Hai, Bachelor, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045093
- Sponsor's protocol ID
- DAMS-01
- Acronym
- David-MS
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2019
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request to the corresponding author
Publications
Zhou M, Chan EW, Hai JJ, Wong CK, Lau YM, Huang D, Lam CC, Tam CCF, Wong YTA, Yung SYA, Chan KWK, Feng Y, Tan N, Chen JY, Yung CY, Lee KL, Choi CW, Lam H, Ng A, Fan K, Jim MH, Yiu KH, Yan BP, Siu CW. Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study. BMJ Open. 2020 Sep 25;10(9):e038194. doi: 10.1136/bmjopen-2020-038194.
PubMed 32978200
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial
- ClinicalTrials.gov ID
- NCT04045093
- Acronym / sponsor ID
- David-MS / DAMS-01
- Conditions
- Atrial Fibrillation, Mitral Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, this group of patients was typically excluded in randomized control trials. As a result, current international guidelines for management of AF do not recommend NOACs for stroke prevention in AF patients with underlying moderate or severe MS. Nonetheless off-label use of NOACs in patients with MS is not uncommon in the real world practice.
This is of particular importance for Asian AF patients, in whom MS remains relatively prevalent despite a declining trend. More importantly, the much higher baseline risk of intracranial haemorrhage and apparently higher ischemic stroke risk in Asian populations potentially undermine the benefits of Warfarin therapy. On the other hand, the efficacy and safety of NOACs compared with Warfarin appear to be even higher in Asian population than the non-Asian population as shown in sub-analyses pivotal randomised control trials as well as in the real world evidence. This study refers as a prospective, randomized, open-label trial with blinded end-point adjudication, aiming at evaluating the safety and efficacy of Dabigatran for stroke prevention in AF patients with underlying moderate or severe MS.
After providing written informed consent, study participants from participating local centres will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran (150mg or 110mg according to creatinine clearance level, twice daily) or Warfarin (targeting in the international normalized ratio (INR) range 2-3) in an open-label design. In a year of individual study period, vital signs, laboratory blood check and adverse events will be monitored, and primary and secondary outcomes will be assessed. The estimated sample size is approximately 370 participants. On addition, a subgroup of patients up to 10% of the target sample size will be invited for an one-time non-invasive magnetic resonance imaging (MRI) for assessment of any intra-cardiac thrombus.
The results will be an important contribution to the stroke prevention strategy for patients with MS and may be immediately translatable to real clinical practice. Ultimately, this study will provide the necessary evidence for establishing universal guidelines for this group of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective study with randomization in 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate | Experimental | Drug: Dabigatran etexilateSubjects randomized into this group will be prescribed with either Dabigatran 150mg or Dabigatran 110mg (twice daily) according to creatinine clearance level) for stroke prevention. |
| Warfarin | Active comparator | Drug: WarfarinSubjects randomized into this group will be prescribed with Warfarin with dosage adjustment according to INR level (targeting to INR 2-3) for stroke prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran etexilateAlso: PradaxaSubjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design. | Drug | Dabigatran etexilate |
| WarfarinSubjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design. | Drug | Warfarin |
Primary outcome
Composite of stroke, systemic embolism, myocardial infarction, and death from cardiovascular or unknown cause.
Time frame: 1 year
Stroke is classified into ischemic or hemorrhagic stroke, as confirmed by computed tomography or magnetic resonance imaging. Systemic embolism is defined as an acute vascular occlusion of an extremity or organ other than the brain, documented by imaging, surgery, and/or autopsy. Myocardial infarction is defined according to the latest ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes, with the assessment of electrocardiography, cardiac troponin values and presence of symptoms. Death is counted when subject is medically certified of death, resulted from cardiovascular or unknown cause.
5 secondary outcomes
Ischemic stroke
Time frame: 1 year
Hemorrhagic stroke
Time frame: 1 year
Systemic embolism
Time frame: 1 year
Major bleeding
Time frame: 1 year
Death
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 32978200Zhou M, Chan EW, Hai JJ, Wong CK, Lau YM, Huang D, Lam CC, Tam CCF, Wong YTA, Yung SYA, Chan KWK, Feng Y, Tan N, Chen JY, Yung CY, Lee KL, Choi CW, Lam H, Ng A, Fan K, Jim MH, Yiu KH, Yan BP, Siu CW. Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study. BMJ Open. 2020 Sep 25;10(9):e038194. doi: 10.1136/bmjopen-2020-038194.
- Individual participant dataSharing planned: Yes. Data will be available on request to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu Han Jo Jo Hai, Bachelor principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran etexilate and Warfarin in people with Atrial Fibrillation and Mitral Stenosis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of stroke, systemic embolism, myocardial infarction, and death from cardiovascular or unknown cause. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.