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ACTIVE NOT RECRUITING
NCT04045093
PHASE4

Dabigatran for Mitral Stenosis Atrial Fibrillation

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Official title: Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2020-10-22

Completion Date

2027-09-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

Dabigatran etexilate

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.

DRUG

Warfarin

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.

Locations (1)

The University of Hong Kong / Queen Mary Hospital

Hong Kong, Hong Kong