Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Cardiovascular Disease (MicroVasc-DIVA)
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|ClinicalTrials.gov Identifier: NCT02164578|
Recruitment Status : Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : September 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetic Patients||Drug: Rivaroxaban Drug: Aspirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Typ-2 Diabetic Patients With Cardiovascular Disease and Subclinical Inflammation|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
Patients receive IMP in 5mg b.i.d. for 20 weeks.
Active Comparator: Aspirin
Patients receive IMP in a dosage of 100mg once daily for 20 weeks.
- forearm blood flow [ Time Frame: 20 weeks ]Difference of change of forearm blood flow with venous occlusion plethysmography at baseline and after forearm ischemia after 20 weeks treatment between rivaroxaban and aspirin therapy
- Laserdopplerfluxmetry (LDF) [ Time Frame: 20 weeks ]change of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)
- Mobilography [ Time Frame: 20 weeks ]Measurement of arterial stiffness measured by Mobilograph (IEM Inc.)
- composite laboratory measurement [ Time Frame: 20 weeks ]
- composit laboratory markers for endothelial function,
- composite of biomarkers of inflammation
- bleeding side effects
- composite laboratory metabolic marker
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164578
|Dresden, Sachsen, Germany, 01067|
|Universitätsmedizin Berlin / Charité Campus Buch|
|Berlin, Germany, 13125|
|Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann|
|Dresden, Germany, 01279|
|GWT-TUD GmbH / Studienzentrum Hanefeld|
|Dresden, Germany, 01307|
|Pirna, Germany, 01796|
|Principal Investigator:||Frank Pistrosch, Dr. med.||GWT-TUD GmbH|