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Completed

NCT Number: NCT02164578

Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk

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.

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Key information

Conditions

Type 2 Diabetic Patients

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Krankenhaus Dresden-Friedrichstadt, Dresden, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes duration between 2 and 20 years
  • Two or more components of metabolic syndrome:
  • HDL-cholesterol < 1.0 mmol/L (in males) or < 1.3 mmol/L (in females)
  • Elevated triglycerides (> 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 < 10 mg/l) at or within 6 months prior to screening and/or increased PAI 1 (> 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 statins (if tolerated/clinically indicated)
  • Age 40 - 75 years

Exclusion criteria

  • Major cardiovascular (CV) event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
  • Sustained uncontrolled hypertension: systolic blood pressure > 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 acute coronary syndrome (ACS) with antiplatelet therapy in patients with a prior stroke or a transient ischemic 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.

Treatment and study plan

Rivaroxaban

Drug

Aspirin

Drug

Primary outcomes

  1. Change in Post-ischemic Forearm Blood Flow

    Time frame: Baseline and week 20

    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.

  2. Change in Pulse Wave Velocity

    Time frame: Baseline and week 52

    Change in pulse wave velocity as a marker of arterial stiffness (measured by IEM Mobil-O-Graph)

Secondary outcomes

  1. Change in Post-ischemic Forearm Blood Flow

    Time frame: Baseline and week 52

    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.

  2. Change in Pulse Wave Velocity

    Time frame: Baseline to week 20

    Change in pulse wave velocity as a marker for arterial stiffness (measured by IEM Mobil-O-Graph)

  3. Change in Skin Blood Flow

    Time frame: Baseline to week 20

    Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)

  4. Change in Skin Blood Flow

    Time frame: Baseline to week 52

    Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)

  5. Major Bleeding

    Time frame: Week 1 to week 20

    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).

  6. Major Bleeding

    Time frame: Week 1 to week 52

    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).

  7. Clinically Relevant Non-major (CRNM) Bleeding

    Time frame: Week 1 to week 20

    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

  8. Clinically Relevant Non-major (CRNM) Bleeding

    Time frame: Week 1 to week 52

    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

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Official study title

Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation

Acronym: MicroVasc-DIVA

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 16, 2014
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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