Status:
UNKNOWN
Influence of Rivaroxaban for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic PAD
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
Poznan University of Physical Education
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50-70 years
Brief Summary
The aim of the conducted research is to evaluate the protective effect of rivaroxaban (trade name of the Xarelto medicinal product), administered together with acetylsalicylic acid (ASA), in compariso...
Detailed Description
EXISTING KNOWLEDGE AND MAIN ASSUMPTIONS OF THE PROJECT. Atherosclerosis is the most common cause of peripheral artery disease (PAD). The first symptom of PAD is intermittent claudication (IC), which ...
Eligibility Criteria
Inclusion
- 1\. PAD, the Fontaine classification II
Exclusion
- Severe heart failure with known ejection fraction \<30% or NYHA class III or IV symptoms
- High risk of bleeding
- Stroke with one month or any history of hemorrhaging or lacunar stroke
- Estimated glomerular filtration rate \<15 ml/ml
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy/, oral anticoagulant therapy/
- The known non-cardiovascular disease that is associated with poor prognosis (i.n, metastatic cancer)
- History of hypersensitivity or known contraindication for rivaroxaban, aspirin
- Systemic treatment with strong inhibitors of CYP 3A4 as well as p-glycoprotein or strong inducers of CYP 3M
- Any known hepatic disease associated with coagulopathy
- Concurrent participation in another study with an investigational drug
- Known contraindication to any study-related procedures\* Concerns: Absolute contraindications to an exercise test
- Respiratory failure
- BMI above or equal 40
- Musculoskeletal dysfunction preventing walking (e.g. amputations)
Key Trial Info
Start Date :
March 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04305028
Start Date
March 10 2021
End Date
December 31 2024
Last Update
March 10 2021
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