Phase 3
N=179
Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk
Type 2 Diabetic Patients
Bottom Line
View on ClinicalTrials.gov: NCT02164578 ↗Enrolled (actual)
179
Serious AEs
5.6%
Results posted
Nov 2023
Primary outcome: Primary: Change in Post-ischemic Forearm Blood Flow — 3.60; 1.00 ml/100ml — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Drug); Aspirin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GWT-TUD GmbH
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Post-ischemic Forearm Blood Flow |
6.11; 1.56 | 0.045 sig |
| PRIMARY Change in Pulse Wave Velocity |
0.02; 0.14 | 0.125 |
| SECONDARY Change in Post-ischemic Forearm Blood Flow |
6.11; 1.56 | 0.045 sig |
| SECONDARY Change in Pulse Wave Velocity |
0.02; 0.14 | 0.125 |
| SECONDARY Change in Skin Blood Flow |
-7.3; 5.8 | 0.589 |
| SECONDARY Change in Skin Blood Flow |
-7.3; 5.8 | 0.589 |
| SECONDARY Major Bleeding |
0; 0 | — |
| SECONDARY Major Bleeding |
0; 0 | — |
| SECONDARY Clinically Relevant Non-major (CRNM) Bleeding |
6; 1 | — |
| SECONDARY Clinically Relevant Non-major (CRNM) Bleeding |
6; 1 | — |
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 1.7 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 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 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.
Data sourced from ClinicalTrials.gov (NCT02164578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.