Clinical trial NCT02164578: Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetic Patients
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 179
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Post-ischemic Forearm Blood Flow
timeFrame: Baseline and week 20
measure: Change in Pulse Wave Velocity
timeFrame: Baseline and week 52
Secondary outcomes:
measure: Change in Post-ischemic Forearm Blood Flow
timeFrame: Baseline and week 52
measure: Change in Pulse Wave Velocity
timeFrame: Baseline to week 20
measure: Change in Skin Blood Flow
timeFrame: Baseline to week 20
measure: Change in Skin Blood Flow
timeFrame: Baseline to week 52
measure: Major Bleeding
timeFrame: Week 1 to week 20
measure: Major Bleeding
timeFrame: Week 1 to week 52
measure: Clinically Relevant Non-major (CRNM) Bleeding
timeFrame: Week 1 to week 20
measure: Clinically Relevant Non-major (CRNM) Bleeding
timeFrame: Week 1 to week 52
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
state: Sachsen
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin / Charité Campus Buch
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. Schaper/ Dr. Faulmann
city: Dresden
country: Germany
facility: GWT-TUD GmbH / Studienzentrum Hanefeld
city: Pirna
country: Germany
facility: Cardiologicum Prina
Study officials:
affiliation: GWT-TUD GmbH
name: Frank Pistrosch, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.