Improvement of cardiovascular outcomes in patients with advanced chronic kidney disease.
Conditions
Interventions
Product Name: Rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Tablet
INN or Proposed INN: Rivaroxaban
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg millig
Sponsors
The George Institute of Global Health
Eligibility
Sex/Gender
All
Inclusion criteria
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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To determine whether, in people with CKD stages 4 or 5 kidney failure or dialysis and an elevated CV risk, low dose rivaroxaban compared to placebo reduces the risk of CV death, all cause death risk, risk of individual components of composite outcomes, and risk of venous thromboembolism.;Primary end point(s): The primary efficacy outcome is a composite of cardiovascular death, non-fatal myocardial infarction, stroke, or peripheral artery disease event.;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 3-point MACE (cardiovascular death, non-fatal myocardial infarction, or stroke), 2. All-cause death, 3. Composite of all-cause death, non-fatal myocardial infarction, or stroke, 4. Composite of all-cause death, non-fatal myocardial infarction, or stroke, or peripheral artery disease event, XML File Identifier: DVFg7GynzItyp0fYxDU9ITtN89M= Page 12/21 5. Individual components of the composite outcomes, 6. Net-clinical-benefit outcome (a composite outcome of cardiovascular death, non-fatal myocardial infarction, stroke, PAD events, fatal bleeding, or symptomatic bleeding into a critical organ), 7. Venous thromboembolism.;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Australia, Belgium, Canada, France, Germany, India, Malaysia, Saudi Arabia, Singapore, Taiwan, Tunisia
Contacts
Public ContactTRACK Project Manager
The George Institute of Global Health
Outcome results
None listed