Status:
COMPLETED
Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients
Lead Sponsor:
Science Valley Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Peripheral Artery Disease
Intermittent Claudication
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
This trial is evaluating if rivaroxaban 2.5 mg BID and aspirin 100 mg OD compared to aspirin alone improves on intermittent claudication distance in PAD patients.
Detailed Description
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 eve...
Eligibility Criteria
Inclusion
- Patients with symptomatic PAD who signed the informed consent form (ICF) with:
- Ankle-brachial index (ABI) \< 0. 85 in at least one member, and
- ACD \< 500 meters
- age \> 18 years
- No history of lower-limbs arterial bypass surgery or angioplasties in the last year
- walking ability limited by the symptom of claudication and
- ability to complete a treadmill test
Exclusion
- 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.
- 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.
- severe heart failure (NYHA class III and VI)
- 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).
- the use of dual antiplatelet therapy, anticoagulation, or other antithrombotic therapy
- Continuous use of pentoxifylline or cilostazol
- Cardiac conditions that may lead to heart failure, such as unstable angina, arrhythmias, acute myocardial infarction in the last three months
- Non-cardiac conditions that may interfere with the ability to complete functional tests (e.g., chronic obstructive pulmonary disease, anemia, rheumatologic diseases)
- 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+)
- \-
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04853719
Start Date
April 20 2021
End Date
November 1 2022
Last Update
August 6 2024
Active Locations (2)
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1
Hospital e Maternidade Christovão da Gama - Science Valley clinical site
Santo André, São Paulo, Brazil, 09030-010
2
Science Valley Research Institute
Santo André, São Paulo, Brazil, 09030370