Rivaroxaban for Advanced chronic kidney disease (CKD stage 4 or 5) | Dialysis-dependent kidney failure | Cardiovascular disease

Inclusion criteria

• {"criterion_text":"- 1. People able to provide informed consent who meet all of the following inclusion criteria"}
• {"criterion_text":"- 2. Age ≥18 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- a. History of CAD or PAD or non-haemorrhagic non-lacunar stroke"}
• {"criterion_text":"- b. Diabetes mellitus"}
• {"criterion_text":"- c. Age ≥65 years"}

Exclusion criteria

• {"criterion_text":"- 1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation)"}
• {"criterion_text":"- 2. Indication for, or contraindication to, anticoagulant therapy"}
• {"criterion_text":"- 3. High bleeding risk including any coagulopathy"}
• {"criterion_text":"- 4. Lesion or condition considered to be a significant risk of major bleeding"}
• {"criterion_text":"- 5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4"}
• {"criterion_text":"- 8. Any stroke within 1 month prior to enrolment"}
• {"criterion_text":"- 9. Any previous history of a haemorrhagic or lacunar stroke"}
• {"criterion_text":"- 10. Severe heart failure with known ejection fraction <30% or NYHA class III or IV symptoms"}
• {"criterion_text":"- 11. History of hypersensitivity or known contraindication to rivaroxaban"}
• {"criterion_text":"- 12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg) at the time of screening"}
• {"criterion_text":"- 13. Haemoglobin <90 g/L, or platelet count <100 x 109/L"}
• {"criterion_text":"- 14. Significant liver disease (defined as Child-Pugh Class B or C) or ALT >3 times upper normal limit"}
• {"criterion_text":"- 15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 17. Inability to understand or comply with the requirements of the study"}

Primary endpoints

• {"endpoint_text":"- •CV death\n- • non-fatal myocardial infarction\n- • stroke\n- • PAD events","definition_or_measurement_approach":"Composite outcome of CV death, non-fatal myocardial infarction, stroke, or peripheral arterial disease events"}

Secondary endpoints

• {"endpoint_text":"- 1.3-point MACE","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2.All-cause death","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3.Composite of all-cause death,non-fatal myocardial infarction,or stroke","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4.Composite of all-cause death, non-fatal myocardial infarction, or stroke, or peripheral artery disease event","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5.Individual components of the composite outcomes","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6.Net-clinical-benefit outcome","definition_or_measurement_approach":""}
• {"endpoint_text":"- 7. Venous thromboembolism","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

19-06-2024

Processing Time Days

86

Number Of Sites

1

Number Of Participants

50

Germany

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

20-06-2024

Processing Time Days

87

Number Of Sites

1

Number Of Participants

200

France

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

07-01-2025

Processing Time Days

214

Number Of Sites

17

Number Of Participants

200

Primary sponsor

Full Name

The George Institute For Global Health

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Australia

Third parties

• {"country":"France","full_name":"France - Ministère de la Santé (Ministry of Health)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"Australia","full_name":"Australia - National Health and Medical Research Council","duties_or_roles":"Source of monetary support","organisation_type":""}