2024-512483-59-00招募中3 期
TRACK - Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced CKD.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 18
- 主要终点
- •CV death, • non-fatal myocardial infarction, • stroke, or • PAD events
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 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.
排除标准
- •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 NYHA 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 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.
结局指标
主要结局
•CV death, • non-fatal myocardial infarction, • stroke, or • PAD events
•CV death, • non-fatal myocardial infarction, • stroke, or • PAD events
次要结局
- 1.3-point MACE , 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, 5.Individual components of the composite outcomes, 6.Net-clinical-benefit outcome 7. Venous thromboembolism.
研究者
Sunil Badve
Scientific
The George Institute For Global Health
研究点 (18)
Loading locations...
相似试验
招募中
4 期
SHORT RUN AF "Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk"2024-516374-29-00Assistance Publique Hopitaux De Paris550
招募中
不适用
Effect of rivaroxaban for anti-atherosclerotic response in atrial fibrillation patientsatrial fibrillationJPRN-UMIN000011129Yokohama Sakae Kyosai Hospital50
进行中（未招募）
1 期
atype 2 diabetic patients with stable peripheral or carotid artery diseaseMedDRA version: 21.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 100000004866MedDRA version: 21.0Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2019-000610-10-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE78
招募中
2 期
Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trialCardiogenic Shock2023-508024-36-00Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken, Medical University Of Vienna46
已完成
不适用
A randomised controlled trial with rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patientsVenous thromboembolism with cancer patientsJPRN-UMIN000026600Chiba Cancer Center100