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

GWT-TUD

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetic Patients

Treatments: Drug: Aspirin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02164578

MicroVasc-DIVA

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban

Aspirin

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin