Dabigatran for Mitral Stenosis Atrial Fibrillation

NCT04045093 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: DAMS-01
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation; Mitral Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• Ischemic stroke

  1 year

• Hemorrhagic stroke

  1 year

• Systemic embolism

  1 year

• Major bleeding

  1 year

• Death

  1 year

Study Arms (2)

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.

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.

Drug: Warfarin

Interventions

Dabigatran etexilate DRUG

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.

Also known as: Pradaxa

Dabigatran etexilate

Warfarin DRUG

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.

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong / Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 32978200 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Mitral Valve Stenosis

Interventions

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Siu Han Jo Jo Hai, Bachelor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective study with randomization in 1:1 ratio

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: October 22, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)