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

NCT04853719 | Completed Phase 4 DMC

• 1 other identifier: ScienceValley
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Artery Disease; Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• Major adverse cardiovascular events (MACE)

  6 months

• Major Adverse Limb Events (MALE)

  6 months

• Major or clinically non-relevant bleeding defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria

  6 months

Study Arms (2)

Vascular dose

EXPERIMENTAL

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

Drug: Rivaroxaban 2.5 Mg Oral Tablet

Aspirin

ACTIVE COMPARATOR

Aspirin 100 mg OD for 6 months

Drug: Rivaroxaban 2.5 Mg Oral Tablet

Interventions

Rivaroxaban 2.5 Mg Oral Tablet DRUG

oral anticoagulants plus antiplatelet agent

Also known as: Aspirin 100 Mg oral Tablet

Aspirin; Vascular dose

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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+)

Sponsors & Collaborators

• Science Valley Research Institute: lead
• Bayer: collaborator

Study Sites (2)

Hospital e Maternidade Christovão da Gama - Science Valley clinical site

Santo André, São Paulo, 09030-010, Brazil

Location

Science Valley Research Institute

Santo André, São Paulo, 09030370, Brazil

Location

Related Publications (2)

• Ramacciotti E, Agati LB, Volpiani GG, Brito KF, Ribeiro CM, Aguiar VCR, Ramacciotti LS, Paganotti A, Pereira FM, Caffaro RA, Fioranelli A, Krakauer R, Rached HRS, Wolosker N, Anand SS, Eikelboom JW, Lopes RD. Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296211073922. doi: 10.1177/10760296211073922.

  PMID: 35043716 BACKGROUND

• Ramacciotti E, Volpiani GG, Britto KF, Agati LB, Ribeiro CM, Aguiar VCR, Paganotti A, Pereira FM, Caffaro RA, Krakauer R, Rached HRS, Fareed J, Wolosker N, Anand SS, Eikelboom JW, Chang C, Lopes RD. Rivaroxaban for Patients with Intermittent Claudication. NEJM Evid. 2024 Sep;3(9):EVIDoa2400021. doi: 10.1056/EVIDoa2400021. Epub 2024 Aug 26.

  PMID: 39185955 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 20, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year

Locations

BR (2)