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

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ClinicalTrials.gov Identifier: NCT04853719
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Science Valley Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Intermittent Claudication Drug: Rivaroxaban 2.5 Mg Oral Tablet Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arms, active comparator (vascular dose) versus aspirin alone
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vascular dose
Rivaroxaban 2.5 mg BID and aspirin 100 mg OD for 6 months
 Drug: Rivaroxaban 2.5 Mg Oral Tablet
oral anticoagulants plus antiplatelet agent
Other Name: Aspirin 100 Mg oral Tablet
Active Comparator: Aspirin
Aspirin 100 mg OD for 6 months
 Drug: Rivaroxaban 2.5 Mg Oral Tablet
oral anticoagulants plus antiplatelet agent
Other Name: Aspirin 100 Mg oral Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Initial claudication distance (ICD) and the total walking distance (TWD) on 6 MWT [ Time Frame: 6 months ]
    Improvement of the initial claudication distance (ICD) and the total walking distance (TWD)

  2. Absolute claudication distance (ACD) on treadmill [ Time Frame: 6 months ]
    ACD is the total distance traveled on a treadmill until it stops due to IC pain.

  3. Quality of life Walking Impairment Questionnaire (WIQ): [ Time Frame: 6 months ]
    A modified version of WiQ will be administered at baseline and 12 and 24 weeks


Secondary Outcome Measures :
  1. Major adverse cardiovascular event [ Time Frame: 6 months ]
    Exploratory: major adverse cardiovascular events - MACE

  2. Major adverse events of the limbs [ Time Frame: 6 months ]
    MALE - acute limb ischemia


Other Outcome Measures:
  1. Bleeding [ Time Frame: 6 months ]
    Exploratory outcomes (major bleeding + clinically non-relevant bleeding) will be used, according to the International Society's bleeding criteria on Thrombosis and Hemostasis (ISTH).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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+)

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853719


Locations
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Brazil
Science Valley Research Institute Recruiting
Santo André, São Paulo, Brazil, 09030370
Contact: Leandro Agati, PhD    +551144688183    agati@svriglobal.com   
Contact: Eduardo Ramacciotti, MD, PhD    +551144688183    ramacciotti@svriglobal.com   
IAMSPE - Sao Paulo Public Servants Hospital Recruiting
São Paulo, Brazil, 04039000
Contact: Rodrigo B Biagioni    11981871545    rbbiagioni@gmail.com   
Principal Investigator: Roberto Sacilotto, PHD         
Sponsors and Collaborators
Science Valley Research Institute
Bayer
More Information
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Responsible Party: Science Valley Research Institute
ClinicalTrials.gov Identifier: NCT04853719    
Other Study ID Numbers: ScienceValley
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data is collected on RedCap, thast allows open and sharing IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 1 year

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants