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Type 2 Diabetic PatientsPhase 3MicroVasc-DIVANCT02164578

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

A Phase 3 study testing Rivaroxaban and Aspirin in people with Type 2 Diabetic Patients, run by GWT-TUD GmbH at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Type 2 Diabetic Patients
What is being tested?
Rivaroxaban and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
5 sitesGermany
Study dates
Apr 2015to 30 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsmedizin Berlin / Charité Campus Buch

    Berlin, 13125

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, Saxony, 01067

  • Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann

    Dresden, 01279

  • GWT-TUD GmbH / Studienzentrum Hanefeld

    Dresden, 01307

  • Cardiologicum Prina

    Pirna, 01796

Other trials in Germany

About this study

Official 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

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.

Being tested
Rivaroxaban, Aspirin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02164578
Study groupRoleWhat they receive
RivaroxabanExperimental5mg b.i.d. for 20 weeks (primary phase) + additional 32 weeks (extension phase)
Receives: Drug: Rivaroxaban
AspirinActive comparator100mg once daily for 20 weeks (primary phase) + additional 32 weeks (extension phase)
Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and week 20

  2. Change in Pulse Wave Velocity

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

    Measured: Baseline and week 52

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and week 52

  2. Change in Pulse Wave Velocity

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

    Measured: Baseline to week 20

  3. Change in Skin Blood Flow

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

    Measured: Baseline to week 20

  4. Change in Skin Blood Flow

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

    Measured: Baseline to week 52

  5. 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).

    Measured: Week 1 to week 20

  6. 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).

    Measured: Week 1 to week 52

  7. 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

    Measured: Week 1 to week 20

  8. 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

    Measured: Week 1 to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion12 Dec 2018
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02164578
Sponsor's protocol ID
MicroVasc-DIVA
Acronym
MicroVasc-DIVA
Status last verified
Jan 2023
First submitted
12 Jun 2014
Last updated
7 Nov 2023
Data monitoring committee
No

Publications

  • Pistrosch F, Matschke JB, Schipp D, Schipp B, Henkel E, Weigmann I, Sradnick J, Bornstein SR, Birkenfeld AL, Hanefeld M. Rivaroxaban compared with low-dose aspirin in individuals with type 2 diabetes and high cardiovascular risk: a randomised trial to assess effects on endothelial function, platelet activation and vascular biomarkers. Diabetologia. 2021 Dec;64(12):2701-2712. doi: 10.1007/s00125-021-05562-9. Epub 2021 Sep 8.

    PubMed 34495376

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban and Aspirin in people with Type 2 Diabetic Patients, run by GWT-TUD GmbH at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Post-ischemic Forearm Blood Flow (time frame: Baseline and week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02164578, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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