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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, Germany
Universitätsmedizin Berlin / Charité Campus Buch
Berlin, Germany
Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann
Dresden, Germany
GWT-TUD GmbH / Studienzentrum Hanefeld
Dresden, Germany
Change in Post-ischemic Forearm Blood Flow
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.
Time frame: Baseline and week 20
Change in Pulse Wave Velocity
Change in pulse wave velocity as a marker of arterial stiffness (measured by IEM Mobil-O-Graph)
Time frame: Baseline and week 52
Change in Post-ischemic Forearm Blood Flow
Difference of change in post-ischemic forearm blood flow measured by venous occlusion plethysmography at baseline and after 52 weeks treatment with rivaroxaban or aspirin.
Time frame: Baseline and week 52
Change in Pulse Wave Velocity
Change in pulse wave velocity as a marker for arterial stiffness (measured by IEM Mobil-O-Graph)
Time frame: Baseline to week 20
Change in Skin Blood Flow
Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)
Time frame: Baseline to week 20
Change in Skin Blood Flow
Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)
Time frame: Baseline to week 52
Major Bleeding
Major bleeding defined as clinically overt and associated with one of the following: 1) reduction of hemoglobin level of 2 g/L or 2) required transfusion of at least 2 units of red cells or, involved a critical organ or was fatal, in accordance with the recommendation of the International Society on Thrombosis and Hemostasis (ISTH).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiologicum Prina
Pirna, Germany
Time frame: Week 1 to week 20
Major Bleeding
Major bleeding defined as clinically overt and associated with one of the following: 1) reduction of hemoglobin level of 2 g/L or 2) required transfusion of at least 2 units of red cells or, involved a critical organ or was fatal, in accordance with the recommendation of the International Society on Thrombosis and Hemostasis (ISTH).
Time frame: Week 1 to week 52
Clinically Relevant Non-major (CRNM) Bleeding
Clinically relevant non-major (CRNM) bleeding defined as at least one of the following: * spontaneous skin hematoma of at least 25 cm * spontaneous nose bleeding of more than 5 minutes duration * macroscopic hematuria, either spontaneous or, if associated with an intervention, lasting more than 24 hours * spontaneous rectal bleeding (more than spotting on toilet paper) * gingival bleeding for more than 5 minutes * bleeding leading to hospitalization and/or requiring surgical treatment * bleeding leading to a transfusion of less than 2 units of whole blood or red cells * any other bleeding event considered clinically relevant by the investigator
Time frame: Week 1 to week 20
Clinically Relevant Non-major (CRNM) Bleeding
Clinically relevant non-major (CRNM) bleeding defined as at least one of the following: * spontaneous skin hematoma of at least 25 cm * spontaneous nose bleeding of more than 5 minutes duration * macroscopic hematuria, either spontaneous or, if associated with an intervention, lasting more than 24 hours * spontaneous rectal bleeding (more than spotting on toilet paper) * gingival bleeding for more than 5 minutes * bleeding leading to hospitalization and/or requiring surgical treatment * bleeding leading to a transfusion of less than 2 units of whole blood or red cells * any other bleeding event considered clinically relevant by the investigator
Time frame: Week 1 to week 52