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Dabigatran for Mitral Stenosis Atrial Fibrillation

Study acronym: David-MS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Study description expanded, about 31 words
    • Site details revised
    v11
  2. Primary endpoints: 2 to 1v10 Show 4 more changesShow less
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 62 words
    • Study site revised
  3. Enrollment target: 686 to 370v9 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2023 to Sep 30, 2026
    • Study completion date: Sep 30, 2024 to Sep 30, 2027
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2020 to Oct 22, 2020
    v8
  5. Start date: Aug 1, 2020 to Oct 1, 2020
    • Primary completion date: Jul 31, 2023 to Sep 30, 2023
    • Study completion date: Jul 31, 2024 to Sep 30, 2024
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jul 1, 2020 to Aug 1, 2020
    • Primary completion date: Jun 30, 2023 to Jul 31, 2023
    • Study completion date: Jun 30, 2024 to Jul 31, 2024
    v6
  2. Start date: Apr 1, 2020 to Jul 1, 2020
    • Primary completion date: Mar 31, 2023 to Jun 30, 2023
    • Study completion date: Mar 31, 2024 to Jun 30, 2024
    v5
  3. Start date: Jan 1, 2020 to Apr 1, 2020
    • Primary completion date: Dec 31, 2022 to Mar 31, 2023
    • Study completion date: Dec 31, 2023 to Mar 31, 2024
    v4
  4. Primary completion date: Sep 30, 2021 to Dec 31, 2022
    • Start date: Oct 1, 2019 to Jan 1, 2020
    • Study completion date: Sep 30, 2022 to Dec 31, 2023
    v3
  5. Start date: Aug 1, 2019 to Oct 1, 2019v2 Show 5 more changesShow less
    • Primary completion date: Jul 31, 2021 to Sep 30, 2021
    • Study completion date: Jul 31, 2022 to Sep 30, 2022
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 4 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04045093
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)		 Atrial Fibrillation, Mitral Stenosis
Related terms Atrial Fibrillation, Mitral Valve Stenosis
Enrollment 370 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov