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Could a common blood thinner replace warfarin for tricky heart valve patients?

NCT ID NCT04045093

Disease control Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares dabigatran (Pradaxa) to warfarin for preventing strokes in 370 people with both atrial fibrillation and moderate-to-severe mitral stenosis. Participants are randomly assigned to one of the two blood thinners. The goal is to see if dabigatran is as good as or better than warfarin at preventing strokes, blood clots, heart attacks, and death, while possibly having fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dabigatran etexilate (Pradaxa)
What this could lead to
If successful, this could provide a safer, more convenient alternative to warfarin for stroke prevention in atrial fibrillation patients with mitral stenosis.
What could go wrong
This is a relatively small, open-label trial, and results may not apply to all patients. Dabigatran may not be as effective or safe as warfarin in this specific population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 370 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation mitral valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Mitral stenosis

Contacts and locations

Locations

  • The University of Hong Kong / Queen Mary Hospital

    Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.