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

NCT02164578 | Completed Phase 3 Results

• 1 other identifier: MicroVasc-DIVA
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetic Patients

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and week 20

• Change in Pulse Wave Velocity

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

  Baseline and week 52

Secondary Outcomes (8)

• Change in Post-ischemic Forearm Blood Flow

  Baseline and week 52

• Change in Pulse Wave Velocity

  Baseline to week 20

• Change in Skin Blood Flow

  Baseline to week 20

• Change in Skin Blood Flow

  Baseline to week 52

• Major Bleeding

  Week 1 to week 20

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

5mg b.i.d. for 20 weeks (primary phase) + additional 32 weeks (extension phase)

Drug: Rivaroxaban

Aspirin

ACTIVE COMPARATOR

100mg once daily for 20 weeks (primary phase) + additional 32 weeks (extension phase)

Drug: Aspirin

Interventions

Rivaroxaban DRUG

Rivaroxaban

Aspirin DRUG

Aspirin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (5)

Krankenhaus Dresden-Friedrichstadt

Dresden, Saxony, 01067, Germany

Location

Universitätsmedizin Berlin / Charité Campus Buch

Berlin, 13125, Germany

Location

Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann

Dresden, 01279, Germany

Location

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, 01307, Germany

Location

Cardiologicum Prina

Pirna, 01796, Germany

Location

Related Publications (1)

• 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.

  PMID: 34495376 DERIVED

MeSH Terms

Interventions

Rivaroxaban; Aspirin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Frank Pistrosch
• Organization: Medical Clinic III, Universitätsklinikum Carl Gustav Carus, Dresden, Germany

frank.pistrosch@uniklinikum-dresden.de

0049 351 458

Study Officials

• Frank Pistrosch, Dr. med.

  GWT-TUD GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: April 1, 2015
• Primary Completion: December 12, 2018
• Study Completion: April 30, 2020
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-01

Locations

DE (5)