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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT04305028
Eligibility Criteria:
Inclusion Criteria:
1\. PAD, the Fontaine classification II
Exclusion Criteria:
1. Severe heart failure with known ejection fraction \<30% or NYHA class III or IV symptoms
2. High risk of bleeding
3. Stroke with one month or any history of hemorrhaging or lacunar stroke
4. Estimated glomerular filtration rate \<15 ml/ml
5. Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy/, oral anticoagulant therapy/
6. The known non-cardiovascular disease that is associated with poor prognosis (i.n, metastatic cancer)
7. History of hypersensitivity or known contraindication for rivaroxaban, aspirin
8. Systemic treatment with strong inhibitors of CYP 3A4 as well as p-glycoprotein or strong inducers of CYP 3M
9. Any known hepatic disease associated with coagulopathy
10. Concurrent participation in another study with an investigational drug
11. Known contraindication to any study-related procedures\* Concerns: Absolute contraindications to an exercise test
12. Respiratory failure
13. BMI above or equal 40
14. Musculoskeletal dysfunction preventing walking (e.g. amputations)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04305028
Study Brief:
Protocol Section:
NCT04305028