Patients with type 2 diabetes and stable cardiovascular disease (CVD) and low grade inflammation
Conditions
Interventions
Trade Name: XARELTO
Product Name: XARELTO
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? type 2 diabetes duration between 2 and 20 years ? two or more components of metabolic syndrome: - HDL cholesterol 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 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 statines (if tolerated) ? age 40 – 75 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 188 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 188
Exclusion criteria
Exclusion criteria: Principal exclusion criteria: ? major CV event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome 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 ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Difference of change of forearm blood flow with venous occlusion plethysmography at baseline and after forearm ischemia after 20 weeks treatment between rivaroxoban and aspirin therapy. Additionally the difference of arterial stiffness after the end of the extension study (week 52) between rivaroxoban and aspirin therapy will be evaluated. ; Secondary Objective: ? change of peripheral skin microcirculatory function after 20 and 52 weeks of treatment ? LDF baseline ? LDF after ischemia (endothelial function) ? arterial stiffness measured after 20 weeks of treatment ? laboratory markers for endothelial function ? VCAM, ICAM, E-Selectin, ADMA, Nitrotyrosin, P-Selectin, CD40-L ? Microalbuminuria, eGFR ? composite of biomarkers of inflammation ? hsCRP, PAI-1, MCP-1, MMP-9, fibrinogen, leucocytes, MPO, IL-6, IL-8 ? side effects: major bleeding according to ISTH, thromboembolic events ? metabolic marker: HbA1c, lipids: triglycerides, LDL-C, HDL-C ? coagulation marker: von Willebrand-Factor, Fibrinogen, Prothrombinfragment, D-Dimer, Protein C, Protein S, TAT, Quick, aPTT ? cardiovascular marker: NT-proBNP, hs-Tnl, GDF-15, MR-ANP Additional secondary objective for extension period: ? Difference of change of forearm blood flow with venous occlusion plethysmography at baseline and after forearm ischemia after 52 weeks treatment ; Primary end point(s): Primary variable ? change of maximal postischemic forearm blood flow during reactive hyperaemia after 5 min of forearm ischemia (FBF max. ml/100ml) at EOT Additional primary variable for extension period: ? pulse wave velocity at EOT after 52 weeks ;Timepoint(s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? change of the area under the postischemic FBF curve over 10 cycles of intermittent venous congestion (compared to baseline) after 20 weeks and EOT Extension ? change of maximal postischemic forearm blood flow during reactive hyperaemia after 5 min of forearm ischemia (FBF max. ml/100ml) at EOT after 52 weeks ? maximal postischemic skin blood flow (arbitrary units) during reactive hyperaemia after 5 min of forearm ischemia at 20 weeks and EOT Extension using LDF ? change of postischemic skin blood flow (compared to baseline) using LDF ? Pulse wave velocity at EOT 20 weeks compared to baseline ? laboratory parameter (see above) at 20 weeks and EOT Extension Additional secondary variable for extension period: ? change of maximal postischemic forearm blood flow during reactive hyperaemia after 5 min of forearm ischemia (FBF max. ml/100ml) at EOT after 52 weeks (EOT Extension) ;Timepoint(s) of evaluation of this end point: 20 weeks and 52 weeks | — |
Countries
Germany
Contacts
Public ContactMedical Consulting
GWT-TUD GmbH
Outcome results
None listed