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

A Prospective, Randomized, Open-label, Multicenter Study Comparing Rivaroxaban 2.5 mg Twice Daily Associated With Aspirin 100 mg Once Daily Versus Aspirin 100 mg Once Daily in Patients With Peripheral Arterial Disease and Limiting Intermittent Claudication. (The COMPASS CLAUDICATION Trial).

Sponsors

Lead Sponsor: Science Valley Research Institute

Collaborator: Bayer

Source Science Valley Research Institute
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 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 daily or aspirin 100 mg once daily for 24 weeks. The primary outcome is the change in claudication distance from baseline to 24 hours as measured by 6 minutes walking test and treadmill test. The main safety outcome is the incidence of major bleeding according to ISTH criteria. Summary: The COMPASS CLAUDICATION trial will provide high-quality evidence regarding the effect of the combination of rivaroxaban and aspirin on claudication distance in patients with peripheral arterial disease.

Overall Status Recruiting
Start Date 2021-02-20
Completion Date 2021-11-30
Primary Completion Date 2021-09-30
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Initial claudication distance (ICD) and the total walking distance (TWD) on 6 MWT 6 months
Absolute claudication distance (ACD) on treadmill 6 months
Quality of life Walking Impairment Questionnaire (WIQ): 6 months
Secondary Outcome
Measure Time Frame
Major adverse cardiovascular event 6 months
Major adverse events of the limbs 6 months
Enrollment 88
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rivaroxaban 2.5 Mg Oral Tablet

Description: oral anticoagulants plus antiplatelet agent

Other Name: Aspirin 100 Mg oral Tablet

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+) -

Gender:

All

Minimum Age:

18 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Location
Facility: Status: Contact: Contact Backup:
Science Valley Research Institute | Santo André, São Paulo, 09030370, Brazil Recruiting Leandro Agati, PhD +551144688183 [email protected]
IAMSPE - Sao Paulo Public Servants Hospital | São Paulo, 04039000, Brazil Recruiting Rodrigo B Biagioni 11981871545 [email protected] Roberto Sacilotto, PHD Principal Investigator
Location Countries

Brazil

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Vascular dose

Type: Experimental

Description: Rivaroxaban 2.5 mg BID and aspirin 100 mg OD for 6 months

Label: Aspirin

Type: Active Comparator

Description: Aspirin 100 mg OD for 6 months

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 2 arms, active comparator (vascular dose) versus aspirin alone

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: open label

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