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Search / Trial NCT04853719

Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients

Launched by SCIENCE VALLEY RESEARCH INSTITUTE · Apr 17, 2021

Trial Information

Current as of May 02, 2025

Completed

Keywords

ClinConnect Summary

Background: The COMPASS trial demonstrated that in patients with peripheral arterial disease the combination of rivaroxaban and aspirin compared with aspirin reduces the risk of major adverse limb events, but it is not known whether this combination can also improve symptoms in patients with intermittent claudication. The primary objective of this study is to evaluate the effect of the combination on intermittent claudication distance.

Study design: Eighty-eight patients with intermittent claudication will be randomized to receive rivaroxaban 2,5 mg twice daily plus aspirin 100 mg once dai...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patients with symptomatic PAD who signed the informed consent form (ICF) with:
  • 1. Ankle-brachial index (ABI) \< 0. 85 in at least one member, and
  • 2. ACD \< 500 meters
  • 3. age \> 18 years
  • 4. No history of lower-limbs arterial bypass surgery or angioplasties in the last year
  • 5. walking ability limited by the symptom of claudication and
  • 6. ability to complete a treadmill test
  • Exclusion Criteria:
  • 1. high risk of bleeding
  • - Evidence of a recent history of bleeding in the last three months, hemorrhagic diathesis in the last three months, changes in coagulation tests (INR\> 1.5 or aPTT \> 2), pulmonary bronchiectasis, active cancer, active gastroduodenal ulcer, use of dual antiplatelet therapy.
  • 2. Recent hemorrhagic stroke (1 month) or any history of previous hemorrhagic or lacunar stroke, if detected by occasional prior tomography, which is not part of the study protocol.
  • 3. severe heart failure (NYHA class III and VI)
  • 4. advanced stable kidney disease (estimated creatinine clearance \<15 ml per minute), defined as eTFG \<15 mL/min by 1.73 m2 calculated by the abbreviated formula Diet Modification in Kidney Disease (MDRD).
  • 5. the use of dual antiplatelet therapy, anticoagulation, or other antithrombotic therapy
  • 6. Continuous use of pentoxifylline or cilostazol
  • 7. Cardiac conditions that may lead to heart failure, such as unstable angina, arrhythmias, acute myocardial infarction in the last three months
  • 8. Non-cardiac conditions that may interfere with the ability to complete functional tests (e.g., chronic obstructive pulmonary disease, anemia, rheumatologic diseases)
  • 9. Non-cardiovascular conditions are considered by the researcher as associated with a poor prognosis.
  • a. Active cancer with a life expectancy of fewer than six months b. Collagen limiting diseases c. Previous or scheduled surgeries that prevent functional evaluation d. Orthopedic diseases that hinder functional evaluation (j) Pregnancy. Women with the potential to bear children should be under contraceptive strategies and take a negative pregnancy test to be enrolled.
  • (k) Patients with COVID in the contagious phase (PCR+)
  • -

About Science Valley Research Institute

Science Valley Research Institute is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong emphasis on scientific integrity and patient safety, the institute conducts a diverse range of clinical studies aimed at evaluating new therapies and medical interventions. Leveraging a multidisciplinary team of experts and state-of-the-art facilities, Science Valley Research Institute collaborates with pharmaceutical companies, academic institutions, and healthcare organizations to drive the discovery of effective treatments that address unmet medical needs. Committed to ethical standards and regulatory compliance, the institute plays a pivotal role in translating scientific breakthroughs into meaningful health solutions for patients worldwide.

Locations

São Paulo, , Brazil

Santo André, São Paulo, Brazil

Santo André, São Paulo, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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