CTRI/2020/06/025708招募中3 期
Treatment of cardiovasculardisease with low dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) - TRACK
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •Potential participants must have NONE of the following exclusion criteria at the time of study
- •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.
研究者
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