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Influence of Rivaroxaban for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic PAD

NCT04305028 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-03-10

No results posted yet for this study

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 comparison with the effectiveness of using ASA alone, in relation to the distance of claudication and exercise tolerance in patients with PAD over a period of 3 months. At present, COMPASS results show that rivaroxaban vascular dose (2.5 mg twice daily) in combination with ASA (75-100 mg once daily) provides more effective cardiovascular protection (defined as cardiovascular death, vascular, myocardial infarction and stroke) compared to ASA alone. So far, however, no scientific studies have been carried out into account the effect of the drug on the progress of PAD and exercise tolerance in patients.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Rivaroxaban

Rivaroxaban 2.5 MG (Xarelto) twice daily, tablet

DRUG

Aspirin

Aspirin 75-100 mg once daily, tablet

Sponsors & Collaborators

  • Poznan University of Physical Education

    collaborator OTHER

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Zbigniew Krasiński, Prof, MD · Poznan University of Medical Sciences

  • Ewa Strauss, PhD · Poznan University of Medical Sciences

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-12-31
Completion
2024-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305028 on ClinicalTrials.gov