The effect of rivaroxaban with aspirin on improving the vascular function in patients with lower extremity arterial disease.
- Conditions
- symptomatic or stable pheripheral artery diseaseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2019-003679-20-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
- Symptomatic or stable lower extremity peripheral artery disease patients (Rutherford stages 1-6) with an indication for single antiplatelet therapy according to international (ESC) guidelines
- 18 years or older
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230
- Patients having or at risk of major bleeding
- 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 CYP3A4 and/or P-glycoprotein inhibitors (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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the effectiveness of low-dose rivaroxaban + aspirin in improving endothelial function (i.e. CAR) in patients with (a) intermittent claudication Rutherford stages 1-3) and (b) critical limb ischemia (Rutherford stages 4-6). ;Secondary Objective: To study the effectiveness of low-dose rivaroxaban with acetylsalicylic acid in decreasing serum endothelin-1 levels in patients with (a) intermittent claudication (Fontaine stages 1-2) and (b) critical limb ischemia (Fontaine stages 3-4).;Primary end point(s): The primary parameter is the dichotomized carotid artery reactivity (CAR) after 3 months treatment. The change in the proportion of patients with CAR constriction from baseline (aspirin alone) to 3 months after adding low-dose rivaroxaban is the primary outcome.;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Exploratory outcomes are serum endothelin-1 levels, major adverse cardiovascular events, major adverse limb events, major bleeding complications and medication adherence.;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment