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

• Sponsor: GWT-TUD GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT02164578
• Collaborator: (none)
• Enrollment: 179
• Locations: 5
• Arms: 2
• Actual Duration (Months): 61
• Patients Per Site: 35.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 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 Type-2 Diabetic Patients With Very High Cardovascular Risk and Subclinical Inflammation
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Dec 12, 2018
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rivaroxaban Patients receive IMP in 5mg b.i.d. for 20 weeks + addidional 32 weeks (extension study for 80 patients)	Drug: Rivaroxaban
Active Comparator: Aspirin Patients receive IMP in a dosage of 100mg once daily for 20 weeks. Thereof 80 patients receive treatment for addidional 32 weeks (extension study)	Drug: Aspirin

Outcome Measures

Primary Outcome Measures

1. Forearm Blood Flow [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) [20 weeks and EOT after 52 weeks (EOT Extension)]

   change of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF)

2. Pulsve wave velocity / augmentation index [20 weeks]

   Measurement of arterial stiffness measured by Mobilograph (IEM Inc.)

3. composite laboratory measurement [20 weeks and EOT after 52 weeks (EOT Extension)]

   composit laboratory markers for endothelial function, composite of biomarkers of inflammation bleeding side effects composite laboratory metabolic marker

4. Forearm Blood Flow [EOT after 52 weeks (EOT Extension)]

   Measurement of change of maximal post-ischemic forearm blood flow

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus Dresden-Friedrichstadt	Dresden	Sachsen	Germany	01067
2	Universitätsmedizin Berlin / Charité Campus Buch	Berlin		Germany	13125
3	Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann	Dresden		Germany	01279
4	GWT-TUD GmbH / Studienzentrum Hanefeld	Dresden		Germany	01307
5	Cardiologicum Prina	Pirna		Germany	01796

Sponsors and Collaborators

• GWT-TUD GmbH

Investigators

• Principal Investigator: Frank Pistrosch, Dr. med., GWT-TUD GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GWT-TUD GmbH
• ClinicalTrials.gov Identifier: NCT02164578
• Other Study ID Numbers: MicroVasc-DIVA
• First Posted: Jun 16, 2014
• Last Update Posted: Feb 15, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Aspirin; Rivaroxaban

Study Results

No Results Posted as of Feb 15, 2021