Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney disease
- Conditions
- Health Condition 1: Z992- Dependence on renal dialysis
- Registration Number
- CTRI/2020/06/025708
- Lead Sponsor
- George Institute for Global Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Age =18 years
2. ESKD 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 Coronary artery disease(CAD) or Peripheral artery disease(PAD) or non-haemorrhagic non-lacunar stroke, OR b. Diabetes mellitus, OR c. Age =65 years
Potential participants must have NONE of the following exclusion criteria at the time of study
enrolment
1.Mechanical/prosthetic heart valve,
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
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 or ALT >3 times upper normal limit
15.Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery
16.Pregnancy or intention to become pregnant or breast-feeding
17.Inability to understand or comply with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary a composite of cardiovascular death, non-fatal myocardial infarction, stroke, and peripheral artery disease event.Timepoint: From baseline till end of the study
- Secondary Outcome Measures
Name Time Method Individual components of the composite outcomes, all-cause death. <br/ ><br>Safety: Major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH), fatal bleeding, non-fatal symptomatic intracranial haemorrhage (ICH), nonfatal, non-ICH, symptomatic bleeding into critical organ, site of major bleeding.Timepoint: From baseline till end of the study