Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * …