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

Primary Purpose

Peripheral Artery Disease, Intermittent Claudication

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Rivaroxaban 2.5 Mg Oral Tablet

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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+)

Sites / Locations

Hospital e Maternidade Christovão da Gama - Science Valley clinical site
Science Valley Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vascular dose

Aspirin

Arm Description

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

Aspirin 100 mg OD for 6 months

Outcomes

Primary Outcome Measures

Initial claudication distance (ICD) and the total walking distance (TWD) on 6 MWT

Improvement of the initial claudication distance (ICD) and the total walking distance (TWD)

Absolute claudication distance (ACD) on treadmill

ACD is the total distance traveled on a treadmill until it stops due to IC pain.

Quality of life Walking Impairment Questionnaire (WIQ):

A modified version of WiQ will be administered at baseline and 12 and 24 weeks

Secondary Outcome Measures

Major adverse cardiovascular event

Exploratory: major adverse cardiovascular events - MACE

Major adverse events of the limbs

MALE - acute limb ischemia

Full Information

NCT ID

NCT04853719

First Posted

April 16, 2021

Last Updated

May 2, 2023

Sponsor

Science Valley Research Institute

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT04853719

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Science Valley Research Institute

Collaborators

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, Intermittent Claudication

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

open label

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vascular dose

Arm Type

Experimental

Arm Description

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

Arm Title

Aspirin

Arm Type

Active Comparator

Arm Description

Aspirin 100 mg OD for 6 months

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 2.5 Mg Oral Tablet

Other Intervention Name(s)

Aspirin 100 Mg oral Tablet

Intervention Description

oral anticoagulants plus antiplatelet agent

Primary Outcome Measure Information:

Title

Initial claudication distance (ICD) and the total walking distance (TWD) on 6 MWT

Description

Improvement of the initial claudication distance (ICD) and the total walking distance (TWD)

Time Frame

6 months

Title

Absolute claudication distance (ACD) on treadmill

Description

ACD is the total distance traveled on a treadmill until it stops due to IC pain.

Time Frame

6 months

Title

Quality of life Walking Impairment Questionnaire (WIQ):

Description

A modified version of WiQ will be administered at baseline and 12 and 24 weeks

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Major adverse cardiovascular event

Description

Exploratory: major adverse cardiovascular events - MACE

Time Frame

6 months

Title

Major adverse events of the limbs

Description

MALE - acute limb ischemia

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Bleeding

Description

Exploratory outcomes (major bleeding + clinically non-relevant bleeding) will be used, according to the International Society's bleeding criteria on Thrombosis and Hemostasis (ISTH).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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+) -

Facility Information:

Facility Name

Hospital e Maternidade Christovão da Gama - Science Valley clinical site

City

Santo André

State/Province

São Paulo

ZIP/Postal Code

09030-010

Country

Brazil

Facility Name

Science Valley Research Institute

City

Santo André

State/Province

São Paulo

ZIP/Postal Code

09030370

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All data is collected on RedCap, thast allows open and sharing IPD

IPD Sharing Time Frame

1 year

Citations:

PubMed Identifier

35043716

Citation

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.

Results Reference

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

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