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Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Cardiovascular Disease (MicroVasc-DIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02164578
Recruitment Status : Unknown
Verified September 2018 by GWT-TUD GmbH.
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : September 13, 2018
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetic Patients Drug: Rivaroxaban Drug: Aspirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rivaroxaban
Patients receive IMP in 5mg b.i.d. for 20 weeks.
Drug: Rivaroxaban
Active Comparator: Aspirin
Patients receive IMP in a dosage of 100mg once daily for 20 weeks.
Drug: Aspirin

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Laserdopplerfluxmetry (LDF) [ Time Frame: 20 weeks ]
    change of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)

  2. Mobilography [ Time Frame: 20 weeks ]
    Measurement of arterial stiffness measured by Mobilograph (IEM Inc.)

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetes duration between 2 and 20 years
  • documented atherosclerotic CVD:
  • major cardiovascular event in medical history or
  • coronary angiography showing a coronary artery stenosis of > 50 % or
  • carotid ultrasound showing an IMT > 1 mm and plaque of carotid artery or
  • left ventricular hypertrophy or
  • macroalbuminuria in the absence of other renal diseases
  • increased hsCRP (> 2 mg/l but < 10 mg/l) and/or increased PAI 1 (> 15 ng/ml)
  • stable treatment with statins (if tolerated)
  • age 40 - 75 years

Exclusion Criteria:

  • CV event with need for oral anticoagulation or dual platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
  • sustained uncontrolled hypertension: systolic bp > 180 mmHg or diastolic bp > 100 mmHg
  • hypersensitivity to the active substance
  • active clinically significant bleeding
  • significant risks 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
  • chronic renal failure with eGFR < 15 ml/min (MDRD formula)
  • Pregnant or breast-feeding woman and woman without adequate method of contraception.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02164578

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Krankenhaus Dresden-Friedrichstadt
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
Cardiologicum Prina
Pirna, Germany, 01796
Sponsors and Collaborators
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Principal Investigator: Frank Pistrosch, Dr. med. GWT-TUD GmbH
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Responsible Party: GWT-TUD GmbH Identifier: NCT02164578    
Other Study ID Numbers: MicroVasc-DIVA
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors