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Can a tiny dose of a common blood thinner protect hearts in kidney failure?

NCT ID NCT03969953

Disease control Sponsor: The George Institute 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a low dose of the blood thinner rivaroxaban (Xarelto) could reduce major heart problems like heart attacks and strokes in people with advanced chronic kidney disease or kidney failure on dialysis. About 1,753 participants were randomly assigned to receive either the drug or a placebo. The goal was to see if the drug lowers the risk of cardiovascular death, heart attack, stroke, or serious artery disease without causing excessive bleeding.

What this could mean

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

Active substance
Rivaroxaban (Xarelto) low-dose tablet
What this could lead to
If successful, this could offer a way to lower the risk of heart attacks, strokes, and related deaths in people with advanced kidney disease who currently have few safe options.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not reduce heart risks in this group, and bleeding is a known risk of blood thinners like rivaroxaban.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,753 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2025

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: * People able to provide informed consent who meet all of the following inclusion criteria: 1. Age ≥18 years, 2. Kidney Failure on haemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy, 3. Elevated cardiovascular risk, defined by at least one of the following: 1. History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or 2. Diabetes mellitus, or 3. Age ≥65 years. Exclusion Criteria: * Potential participants must have none of the following exclusion criteria at the time of study enrolment: 1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation), 2. Indication for, or contraindication to, anticoagulant therapy, 3. High bleeding risk including any coagulopathy, 4. Lesion or condition considered to be a significant risk of major bleeding, 5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding, 6. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications, 7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4, 8. Any stroke within 1 month prior to enrolment, 9. Any previous history of a haemorrhagic or lacunar stroke, 10. Severe heart failure with known ejection fraction \<30% or New York Heart Association class III or IV symptoms, 11. History of hypersensitivity or known contraindication to rivaroxaban, 12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening 13. Haemoglobin \<90 g/L, or platelet count \<100 x 109/L, 14. Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) \>3 times upper normal limit, 15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery, 16. All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding; Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes, 17. Inability to understand or comply with the requirements of the study.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder chronic kidney disease chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

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

Cardiovascular disease Chronic kidney diseases Dialysis-dependent kidney failure

Contacts and locations

Locations

  • AIIMS Bhubaneswar

    Bhubaneswar, India

  • AURAL Colmar, (AURAL Colmar)

    Colmar, 68000, France

  • AURAL Haguenau, (AURAL Haguenau)

    Haguenau, 67500, France

  • AURAL Mulhouse, (AURAL Mulhouse)

    Mulhouse, 68100, France

  • AURAL Strasbourg, (AURAL Strasbourg)

    Strasbourg, 67000, France

  • AZ Sint-Jan Brugge

    Bruges, Belgium

  • All India Institute Of Medical Sciences, Raipur

    Raipur, Chhattisgarh, 700020, India

  • All India Institute of Medical Sciences, Bathinda

    Bathinda, Punjab, 151001, India

  • Apollo Hospital

    Chennai, Tamil Nadu, India

  • Asian Institute of Nephrology and Urology

    Hyderabad, India

  • Aykai Super Speciality Hospital, Ludhiana

    Ludhiana, Punjab, 141010, India

  • Aysha Hospital

    Chennai, Tamil Nadu, 600010, India

  • Bendigo Health

    Bendigo, Victoria, 3552, Australia

  • CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)

    Boulogne-sur-Mer, 62200, France

  • CH Haguenau, (CH Haguenau)

    Haguenau, 67500, France

  • CH Le Puy-en-Velay

    Le Puy-en-Velay, France

  • CH Mulhouse, (CH Mulhouse)

    Mulhouse, 68100, France

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Centre Hospitalier Régional Universitaire de Nancy

    Nancy, Meurthe-et-Moselle, 54035, France

  • Chang Gung Memorial Hospital, Linkou Medical Center

    Taoyuan, 333, Taiwan

  • Charles Nicolle Hospital

    Tunis, Tunisia

  • Chung-Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Citizens Hospital

    Hyderabad, Telangana, 500019, India

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Dialysis Centre - King Abdul Aziz Medical City (KAMC)

    Ar Rimāyah, Riyadh Region, 11481, Saudi Arabia

  • Fattouma Bourguiba Hospital

    Monastir, Tunisia

  • Fu-Jen Catholic University Hospital

    Taishan, New Taipei City, 243, Taiwan

  • Government Hospital

    Nandyāl, 518501, India

  • Government Hospital

    Proddatūr, 516362, India

  • Hedi chaker Hospital

    Sfax, Tunisia

  • Hemodialysis Care Project North Centre

    Al Yāsamīn, Riyadh Region, 13322, Saudi Arabia

  • Hemodialysis Care Project South Centre

    Riyadh, Riyadh Region, 12799-6176, Saudi Arabia

  • Hemodialysis King Abdullah Centre

    Al Yāsamīn, Riyadh Region, 13322, Saudi Arabia

  • Hopital Louis Pasteur (CH Colmar)

    Colmar, France

  • Hospital Ampang

    Ampang, Malaysia

  • Hospital Canselor Tuanku Muhriz

    Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

  • Hospital Kajang

    Kajang, Selangor, 43000, Malaysia

  • Hospital Pakar Sultanah Fatimah Muar

    Muar town, Malaysia

  • Hospital Queen Elizabeth, Kota Kinabalu

    Kota Kinabalu, Sabah, 88200, Malaysia

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586, Malaysia

  • Hospital Raja Permaisuri Bainun, Ipoh

    Ipoh, Perak, 30450, Malaysia

  • Hospital Seberang Jaya

    Seberang Jaya, Pulau Pinang, 13700, Malaysia

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460, Malaysia

  • Hospital Tuanku Ja'afar, Seremban

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Hôpital Bretonneau, (CHRU Tours)

    Tours, 37000, France

  • Hôpital Edouard Herriot, (CHU Lyon)

    Lyon, 69003, France

  • Hôpital Pasteur, (CHU Nice)

    Nice, 06000, France

  • Hôpital de la Cavale Blanche, (CHU Brest)

    Brest, 29200, France

  • Hôpital de la Conception, (AP-HM)

    Marseille, 13005, France

  • Hôpital de la Maison Blanche, (CHU Reims)

    Reims, 51092, France

  • Hôpitaux de Brbaois, (ALTIR)

    Vandœuvre-lès-Nancy, 54500, France

  • Institute of Post-Graduate Medical Education and Research

    Kolkata, 700020, India

  • KG Hospital, K.Govindaswamy Naidu Medical Trust

    Coimbatore, 641018, India

  • KRH Klinikum Siloah

    Hanover, Germany

  • Kaohsiung Chang-Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Khoo Teck Puat Hospital

    Singapore, 767828, Singapore

  • King Abdulaziz Medical City - Western Region - Jeddah, Ministry of National Guard - Health Affairs

    Jeddah, Saudi Arabia

  • King Saud University Medical City (KSUMC)

    Riyadh, Saudi Arabia

  • La Rabta Hospital

    Tunis, Tunisia

  • Logan Hospital

    Meadowbrook, Queensland, 4131, Australia

  • Military Hospital

    Tunis, Tunisia

  • Mongi Slim Hospital

    Tunis, Tunisia

  • Muljibhai Patel Urological Hospital

    Nadiād, Gujarat, 387001, India

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, India

  • Nizam's Institute of Medical Sciences, Hyderabad

    Hyderabad, Telangana, 500082, India

  • Noble Annex Hospital

    Hadapsar, Pune Maharashtra, 411013, India

  • Nutema Hospital

    Meerut, Uttar Pradesh, India

  • Osmania General Hospital

    Hyderabad, Telangana, 500012, India

  • Postgraduate Institute of Medical Education and Research, Chandigarh

    Chandigarh, 160012, India

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Research St. Joseph's - Hamilton

    Hamilton, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Safdarjung Hospital

    New Delhi, India

  • Sahloul Hospital

    Sousse, Tunisia

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • Taher Sfar Hospital

    Tunis, Tunisia

  • Taipei Tzu Chi Hospital

    Taipei, 231, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Tribhuvan University College

    Kathmandu, Nepal

  • University of Alberta

    Edmonton, Canada

  • University of Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • VS Hospital

    Kilpauk, 600010, India

  • Wan fang Hospital

    Taipei, 116, Taiwan

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

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