Peripheral Artery DiseasePhase 4NCT04853719
Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Peripheral Artery Disease and Intermittent Claudication, run by Science Valley Research Institute at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Rivaroxaban 2.5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Apr 2021to 1 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
- 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.
- Patients with COVID in the contagious phase (PCR+)
- -
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital e Maternidade Christovão da Gama - Science Valley clinical site
Santo André, São Paulo, 09030-010
Science Valley Research Institute
Santo André, São Paulo, 09030370
About this study
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).
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.
Read the 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.
- Being tested
- Rivaroxaban 2.5 Mg Oral Tablet
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 Mg Oral TabletDrug
Also called Aspirin 100 Mg oral Tablet
oral anticoagulants plus antiplatelet agent
| Study group | Role | What they receive |
|---|---|---|
| Vascular dose | Experimental | Rivaroxaban 2.5 mg BID and aspirin 100 mg OD for 6 months Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet |
| Aspirin | Active comparator | Aspirin 100 mg OD for 6 months Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total walking distance (TWD) at week 24 in meters in the 6-Minute Walk Test (6MWT)
Measured: 6 months
Secondary outcomes (2)
Change from baseline in the total walking distance (TWD) at week 24 in meters in the treadmill test (TMT)
Measured: 6 months
Change from baseline in the Quality of Life Walking Impairment Questionnaire (WIQ) from at week 24
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 Apr 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms, active comparator (vascular dose) versus aspirin alone
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853719
- Sponsor's protocol ID
- ScienceValley
- Status last verified
- Aug 2024
- First submitted
- 16 Apr 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data is collected on RedCap, thast allows open and sharing IPD
Publications
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.
PubMed 35043716Ramacciotti 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.
PubMed 39185955
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04853719
- Acronym / sponsor ID
- ScienceValley
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Science Valley Research InstituteUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms, active comparator (vascular dose) versus aspirin alone
| Arm | Type | Receives |
|---|---|---|
| Vascular dose | Experimental | Drug: Rivaroxaban 2.5 Mg Oral TabletRivaroxaban 2.5 mg BID and aspirin 100 mg OD for 6 months |
| Aspirin | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral TabletAspirin 100 mg OD for 6 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with symptomatic PAD who signed the informed consent form (ICF) with:
Key exclusion criteria (13 listed)
- high risk of bleeding
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 Mg Oral TabletAlso: Aspirin 100 Mg oral Tabletoral anticoagulants plus antiplatelet agent | Drug | Aspirin, Vascular dose |
Primary outcome
Change from baseline in the total walking distance (TWD) at week 24 in meters in the 6-Minute Walk Test (6MWT)
Time frame: 6 months
2 secondary outcomes
Change from baseline in the total walking distance (TWD) at week 24 in meters in the treadmill test (TMT)
Time frame: 6 months
Change from baseline in the Quality of Life Walking Impairment Questionnaire (WIQ) from at week 24
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 35043716Ramacciotti 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.
- Derived from this study: PubMed 39185955Ramacciotti 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.
- Individual participant dataSharing planned: Yes. All data is collected on RedCap, thast allows open and sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Peripheral Artery Disease and Intermittent Claudication, run by Science Valley Research Institute at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total walking distance (TWD) at week 24 in meters in the 6-Minute Walk Test (6MWT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.