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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 : 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
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date September 13, 2018
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • 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.)
  • laboratory measurement [ Time Frame: 20 weeks ]
    • laboratory markers for endothelial function,
    • composite of biomarkers of inflammation
    • bleeding side effects
    • metabolic marker
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Cardiovascular Disease
Official Title  ICMJE Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Typ-2 Diabetic Patients With Cardiovascular Disease and Subclinical Inflammation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetic Patients
Intervention  ICMJE
  • Drug: Rivaroxaban
  • Drug: Aspirin
Study Arms  ICMJE
  • Experimental: Rivaroxaban
    Patients receive IMP in 5mg b.i.d. for 20 weeks.
    Intervention: Drug: Rivaroxaban
  • Active Comparator: Aspirin
    Patients receive IMP in a dosage of 100mg once daily for 20 weeks.
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2014)
188
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02164578
Other Study ID Numbers  ICMJE MicroVasc-DIVA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GWT-TUD GmbH
Study Sponsor  ICMJE GWT-TUD GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Pistrosch, Dr. med. GWT-TUD GmbH
PRS Account GWT-TUD GmbH
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP