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Blood thinner warfarin under scrutiny for dialysis patients with irregular heartbeat

NCT ID NCT03862859

Disease control Sponsor: Nicholas Carlson Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether the blood thinner warfarin can safely reduce stroke risk in people with end-stage kidney disease on dialysis who also have atrial fibrillation (an irregular heartbeat). About 718 adults will be randomly assigned to take warfarin or not, and researchers will track strokes and major bleeding over time. The goal is to find out if the benefits outweigh the risks in this high-risk group.

What this could mean

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

Active substance
Warfarin (a blood thinner)
What this could lead to
If it works, this could clarify whether warfarin is safe and effective for preventing strokes in dialysis patients with atrial fibrillation.
What could go wrong
This is a Phase 4 trial, but results may not apply to all patients. Warfarin carries a known risk of major bleeding, especially in dialysis patients.

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 718 people

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

Started

Oct 2019

Expected to finish

Jan 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 ≥18 years on chronic dialysis due to end-stage renal disease * Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for \>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device. * Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent. Exclusion Criteria: * CHA2DS2-VASc Score ≤1 * Other indications for oral anticoagulation treatment (pulmonary embolism \< 6 months, deep vein thrombosis \<3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented * Ongoing dual antiplatelet treatment * Malignancy (with exception of non-melanoma skin cancer) with recent \< 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and/or scheduled surgical therapy * Endoscopy with gastrointestinal ulcer \<1 month * Esophageal varices * Autoimmune og genetic coagulation disorders * Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption * Pending spinal tap * Cerebrovascular malformations * Arterial aneurysms * Ulcers or wounds (Wagner grad \>1) * Bacterial endocarditis \< 3 months * Active bleeding contraindicating anticoagulation * Any non-elective and/or non-ambulant surgery \<7 days * Cerebral hemorrhage \<4 weeks * Thrombocytopenia (platelet count \<100 × 109/L) \<30 days. * Severe liver insufficiency (spontaneous international normalized ratio \>1.5) \<30 days. * Known intolerance to warfarin * Use of hypericum perforatum / St. John's Wort * Uncontrolled hypertension (repeat blood pressure \>180/110 mmhg) \< 30 days * Uncontrolled hyperthyroidism (thyroid-stimulating hormone \<0.1μIU/mL) \<30 days * Pregnancy or lactation * Participation in other ongoing intervention trials adjudged to influence study outcomes

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Conditions

The condition(s) this trial relates to.

atrial fibrillation chronic kidney disease end stage renal failure stroke disorder ischemic stroke prevention target

As listed by the trial registrant

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

Atrial fibrillation and flutter End stage renal disease Major bleed Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg University Hosptial

    RECRUITING

    Aalborg, 9100, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Bornholms Hospital

    RECRUITING

    Rønne, 3700, Denmark

  • Department of Nephrology, Copenhagen University Hospital Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Department of Nephrology, Herlev Hospital

    RECRUITING

    Herlev, Herlev, 2730, Denmark

  • Department of nephrology, Nordsjaellands Hospital

    RECRUITING

    Hillerød, Hillerød, 3400, Denmark

  • Esbjerg and Grindsted Hospital

    RECRUITING

    Esbjerg, 6700, Denmark

  • Holbaek Hospital

    RECRUITING

    Holbæk, 4300, Denmark

  • Holstebro Hospital

    RECRUITING

    Holstebro, 7500, Denmark

  • Hospital Sønderjylland

    RECRUITING

    Sønderborg, 6400, Denmark

  • Lillebælt Hospital

    RECRUITING

    Kolding, Denmark

  • Viborg Regional Hospital

    RECRUITING

    Viborg, 8800, Denmark

  • Zealand University Hospital

    RECRUITING

    Roskilde, 4000, Denmark

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