DUAL Pathway Inhibition to Improve Endothelial Function in Peripheral Artery Disease
- Conditions
- Peripheral arterial disease
- Registration Number
- NL-OMON28220
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 159
• Symptomatic or stable lower extremity PAD patients (Rutherford stages 1-6) with an indication for single antiplatelet therapy according to international (ESC) guidelines
• >16 years old
• Patients having or at risk of major bleeding:
? Gastrointestinal ulceration
? Current malignant neoplasms
? Brain or spinal injury
? Brain, spinal or ophthalmic surgery
? Intracranial hemorrhage
? Known or suspected esophageal varices
? Arteriovenous malformations
? Major intraspinal or intracerebral vascular abnormalities
? Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child Pugh B and C
? Use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Patients with prosthetic valves
• Patients with a history of asthma attacks caused by salicylates
• Severe renal impairment (creatinine clearance <30 ml/min)
• Systemic treatment with strong CYP3A4 and/or P-glycoprotein inhibitors (i.e. azole-antimyotics, HIV protease inhibitors)
• Concomitant treatment with other anticoagulants
• Concomitant treatment with methotrexate at a weekly dosage of >15 mg
• Pregnant or lactating
• Known hypersensitivity to Aspirin or rivaroxaban
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the CAR after 3 months combination treatment. The change in proportion of patients with CAR-constriction from baseline (Aspirin alone) to 3 months after adding low dose rivaroxaban will be compared for both study groups (A and B).
- Secondary Outcome Measures
Name Time Method Serum endothelin-1 levels will be quantified as a marker for cardiovascular disease at baseline and 3 months after adding low dose rivaroxaban.