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
- Diseases
- Chronic kidney disease
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az Sint-Lucas Coordinator of this site? Confirm its status | Brugge | Belgium | Completed |
| Klinikum Region Hannover GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Centre Hospitalier de Boulogne-Sur-Mer Coordinator of this site? Confirm its status | Boulogne-sur-Mer | France | Completed |
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Completed |
| Aural Coordinator of this site? Confirm its status | Colmar | France | Completed |
| Centre Hospitalier De Colmar Coordinator of this site? Confirm its status | Colmar Cedex | France | Completed |
| AURAL Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Completed |
| Centre Hospitalier de Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Completed |
| Centre Hospitalier Du Puy Coordinator of this site? Confirm its status | Le Puy-En-Velay | France | Completed |
| Hospital Edouard Herriot Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Aural Coordinator of this site? Confirm its status | Mulhouse | France | Completed |
| Groupe Hospitalier de la Région de Mulhouse et Sud Alsace Coordinator of this site? Confirm its status | Mulhouse | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Completed |
| AURAL Clinique Sainte-Anne Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Completed |
| Ass Lorraine Traitement Insuffis Renale Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.