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

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Treatments: Anti-Inflammatory Agents; Aspirin; Rivaroxaban

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.