Fact CheckerSign in

NCT03969953CompletedPhase 3

Treatment of heart and blood vessel disease (cardiovascular disease) with low dose blood thinner (low dose rivaroxaban) in people with advanced kidney disease or receiving dialysis (advanced chronic kidney disease).

TRACK - Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced CKD.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Jan 2025

Brief summary (registry, in English)

To determine whether low dose rivaroxaban (2.5mg twice daily), compared to placebo, significantly reduces the risk of a composite outcome of Cardio vascular (CV) death, non-fatal myocardial infarction, stroke or peripheral arterial disease events, in patients with chronic kidney disease stages 4 or 5 or dialysis-dependent kidney failure, and an elevated CV risk.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
450 (actual)
First submitted
15 May 2024
Start date
9 Jun 2023
Lead sponsor
The George Institute For Global Health
NCT number
NCT03969953
EU CT number
2024-512483-59-00
EudraCT number
2020-000334-17

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 450
  • 19 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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 NYHA 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 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.

Who the study is looking for

  • People able to provide informed consent who meet all of the following inclusion criteria, 2. Age ≥18 years, 3. 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, 4. Elevated CV risk, defined by at least one of the following: a. History of CAD or PAD or non-haemorrhagic non-lacunar stroke, OR b. Diabetes mellitus, OR c. Age ≥65 years.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Az Sint-Lucas
Coordinator of this site? Confirm its status
BruggeBelgiumCompleted
Klinikum Region Hannover GmbH
Coordinator of this site? Confirm its status
HanoverGermanyCompleted
Centre Hospitalier de Boulogne-Sur-Mer
Coordinator of this site? Confirm its status
Boulogne-sur-MerFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
Coordinator of this site? Confirm its status
Brest Cedex 2FranceCompleted
Aural
Coordinator of this site? Confirm its status
ColmarFranceCompleted
Centre Hospitalier De Colmar
Coordinator of this site? Confirm its status
Colmar CedexFranceCompleted
AURAL Haguenau
Coordinator of this site? Confirm its status
HaguenauFranceCompleted
Centre Hospitalier de Haguenau
Coordinator of this site? Confirm its status
HaguenauFranceCompleted
Centre Hospitalier Du Puy
Coordinator of this site? Confirm its status
Le Puy-En-VelayFranceCompleted
Hospital Edouard Herriot
Coordinator of this site? Confirm its status
Lyon Cedex 03FranceCompleted
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Aural
Coordinator of this site? Confirm its status
MulhouseFranceCompleted
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Coordinator of this site? Confirm its status
MulhouseFranceCompleted
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceCompleted
Centre Hospitalier Universitaire Reims
Coordinator of this site? Confirm its status
Reims CedexFranceCompleted
AURAL Clinique Sainte-Anne
Coordinator of this site? Confirm its status
StrasbourgFranceCompleted
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Tours Cedex 9FranceCompleted
Ass Lorraine Traitement Insuffis Renale
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceCompleted
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceCompleted

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.