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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rivaroxaban

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

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Aspirin

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Interventions

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Rivaroxaban

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No