Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

Laborértékek

• Potential participants must have none of the following exclusion criteria at the time of study enrolment:
  • Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
  • Indication for, or contraindication to, anticoagulant therapy,
  • High bleeding risk including any coagulopathy,
  • Lesion or condition considered to be a significant risk of major bleeding,
  • Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
  • 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,
  • Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
  • Any stroke within 1 month prior to enrolment,
  • Any previous history of a haemorrhagic or lacunar stroke,
  • Severe heart failure with known ejection fraction <30% or New York Heart Association class III or IV symptoms,
  • History of hypersensitivity or known contraindication to rivaroxaban,
  • Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening
  • Haemoglobin <90 g/L, or platelet count <100 x 109/L,
  • Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) >3 times upper normal limit,
  • Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
  • 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,
  • Inability to understand or comply with the requirements of the study.

• People able to provide informed consent who meet all of the following inclusion criteria:
  • Age ≥18 years,
  • 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,
  • Elevated cardiovascular risk, defined by at least one of the following:
  • History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
  • Diabetes mellitus, or
  • Age ≥65 years.