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

Peripheral Artery Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853719
• Other study ID #: ScienceValley
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: Science Valley Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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+)

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Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Rivaroxaban 2.5 Mg Oral Tablet
oral anticoagulants plus antiplatelet agent

Locations

Country	Name	City	State
Brazil	Hospital e Maternidade Christovão da Gama - Science Valley clinical site	Santo André	São Paulo
Brazil	Science Valley Research Institute	Santo André	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Science Valley Research Institute	Bayer

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding	Exploratory outcomes (major bleeding + clinically non-relevant bleeding) will be used, according to the International Society's bleeding criteria on Thrombosis and Hemostasis (ISTH).	6 months
Primary	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)	6 months
Primary	Absolute claudication distance (ACD) on treadmill	ACD is the total distance traveled on a treadmill until it stops due to IC pain.	6 months
Primary	Quality of life Walking Impairment Questionnaire (WIQ):	A modified version of WiQ will be administered at baseline and 12 and 24 weeks	6 months
Secondary	Major adverse cardiovascular event	Exploratory: major adverse cardiovascular events - MACE	6 months
Secondary	Major adverse events of the limbs	MALE - acute limb ischemia	6 months