Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 179
- 试验地点
- 5
- 主要终点
- Change in Post-ischemic Forearm Blood Flow
研究概览
简要总结
Study to investigate microvascular and antiinflammatory effects of Rivaroxaban compared to low dose aspirin in type 2 diabetic patients.
Especially patients with cardiovascular disease and subclinical inflammation are in the focus of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes duration between 2 and 20 years
- •Two or more components of metabolic syndrome:
- •HDL-cholesterol < 1.0 mmol/L (in males) or < 1.3 mmol/L (in females)
- •Elevated triglycerides (> 1.7 mmol/L)
- •Elevated blood pressure (> 130 mmHg systolic and/or >85 mmHg diastolic or antihypertensive treatment)
- •Elevated waist circumference (> 102 cm in males, > 85 cm in females)
- •Or at least one of the following
- •Carotid ultrasound showing an IMT > 1 mm and plaque of carotid artery or
- •Left ventricular hypertrophy or
- •Increased UACR in the absence of other renal diseases than diabetic nephropathy
- •Increased hsCRP (> 2 mg/l but < 10 mg/l) at or within 6 months prior to screening and/or increased PAI 1 (> 15 ng/ml) at or within 6 months prior to screening (the historical hsCRP or PAI 1 value can be used only if the patient was in stable conditions regarding the concomitant diseases and statin therapy since the time point of measurement)
- •Stable treatment with statins (if tolerated/clinically indicated)
- •Age 40 - 75 years
排除标准
- •Major cardiovascular (CV) event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
- •Sustained uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
- •Hypersensitivity to the active substance or to any of the excipients
- •Active clinically significant bleeding
- •Lesion or condition, if considered to be a significant risk for major bleeding
- •Concomitant treatment of acute coronary syndrome (ACS) with antiplatelet therapy in patients with a prior stroke or a transient ischemic attack (TIA)
- •Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- •Chronic renal failure with eGFR < 15 ml/min (MDRD formula)
- •Pregnant or breast-feeding woman and woman without adequate method of contraception.
研究组 & 干预措施
Rivaroxaban
5mg b.i.d. for 20 weeks (primary phase) + additional 32 weeks (extension phase)
干预措施: Rivaroxaban (Drug)
Aspirin
100mg once daily for 20 weeks (primary phase) + additional 32 weeks (extension phase)
干预措施: Aspirin (Drug)
结局指标
主要结局
Change in Post-ischemic Forearm Blood Flow
时间窗: Baseline and week 20
Change of maximal postischemic forearm blood flow during reactive hyperaemia after 5 min of forearm ischemia (FBF max. ml/100ml). Difference of change in post-ischemic forearm blood flow measured by venous occlusion plethysmography at baseline and after 20 weeks treatment with rivaroxaban or aspirin.
Change in Pulse Wave Velocity
时间窗: Baseline and week 52
Change in pulse wave velocity as a marker of arterial stiffness (measured by IEM Mobil-O-Graph)
次要结局
- Major Bleeding(Week 1 to week 52)
- Change in Post-ischemic Forearm Blood Flow(Baseline and week 52)
- Change in Pulse Wave Velocity(Baseline to week 20)
- Change in Skin Blood Flow(Baseline to week 52)
- Clinically Relevant Non-major (CRNM) Bleeding(Week 1 to week 52)