DUAL pathway inhibition (low-dose rivaroxaban and aspirin) as compared to aspirin only to improve endothelial function in peripheral artery disease (PAD)

Phase 4

Completed

Conditions: lower extremity arterial disease
peripheral artery disease
PAD
10003216

Registration Number: NL-OMON49319

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 159

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in the proportion of patients with CAR constriction from baseline<br /><br>(aspirin alone) to 3 months after adding low-dose rivaroxaban is the primary<br /><br>outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>- the change in endothelin-1 levels from baseline (aspirin alone) to 3 months<br /><br>after adding low-dose rivaroxaban is the secondary outcome.<br /><br><br /><br>Other parameters are:<br /><br>- Baseline values (gender, age, height, weight, smoking, comorbidities<br /><br>(hyperlipidemia, hypertension, and diabetes) and medication use<br /><br>- Major adverse cardiovascular events<br /><br>- Major adverse limb events<br /><br>- Major bleeding complications<br /><br>- Medication adherence</p><br>