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

Phase 4

Completed

• Conditions: Peripheral Artery Disease; Intermittent Claudication
• Interventions: Drug: Rivaroxaban 2.5 Mg Oral Tablet

• Registration Number: NCT04853719
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-17
• Study Start: 2021-04-20
• Study First Posted: 2021-04-21
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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+)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vascular dose	Rivaroxaban 2.5 Mg Oral Tablet	Rivaroxaban 2.5 mg BID and aspirin 100 mg OD for 6 months
Aspirin	Rivaroxaban 2.5 Mg Oral Tablet	Aspirin 100 mg OD for 6 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in the total walking distance (TWD) at week 24 in meters in the 6-Minute Walk Test (6MWT)	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the total walking distance (TWD) at week 24 in meters in the treadmill test (TMT)	6 months
Change from baseline in the Quality of Life Walking Impairment Questionnaire (WIQ) from at week 24	6 months

Trial Locations

Locations (2)

Science Valley Research Institute; 🇧🇷 Santo André, São Paulo, Brazil

Hospital e Maternidade Christovão da Gama - Science Valley clinical site; 🇧🇷 Santo André, São Paulo, Brazil