Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk
Condition: Type 2 Diabetic Patients
MeSH terms: Inflammation
Intervention: Rivaroxaban; Aspirin
Intervention MeSH terms: Aspirin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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

          -  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.