Peripheral arterial disease
Conditions
Interventions
Aspirin 100mg once a day + 2.5 mg rivaroxaban twice a day (combination therapy). The use of Aspirin alone (100 mg once a day) during the run-in period is used as reference.
Sponsors
Radboud University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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 15 mg • Pregnant or lactating • Known hypersensitivity to Aspirin or rivaroxaban
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum endothelin-1 levels will be quantified as a marker for cardiovascular disease at baseline and 3 months after adding low dose rivaroxaban. | — |
Contacts
Public ContactLoes Willems
Radboudumc
Outcome results
None listed