Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04218656
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic or stable lower extremity PAD patients (Fontaine stages 2-4) with an indication for single antiplatelet therapy according to international (ESC) guidelines
* \>16 years old
* Written informed consent
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 \<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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04218656
Study Brief:
Protocol Section:
NCT04218656