Peripheral Atherosclerotic DiseasePRO-PASNCT06239415
PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)
An observational study of Peripheral Atherosclerotic Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The observational, prospective, multicenter study enrolls patients experiencing symptomatic peripheral atherosclerotic disease in the lower limb, with or without chronic ischemic heart disease, and who have an indication for treatment with rivaroxaban 2.5 mg twice daily and ASA 100 mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Atherosclerotic Disease
- What is being tested?
- observation
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2022to 31 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg
Who may be able to join
- Patients with symptomatic peripheral atherosclerotic disease of the lower extremity
- Ability to provide written informed consent.
Who cannot join
- Need for dual antiplatelet therapy, or therapy with antiplatelet agents other than aspirin or oral anticoagulant therapy (full dose)
- Ischemic stroke within the previous 1 month or any history of hemorrhagic or lacunar stroke
- Dialysis or estimated glomerular filtration rate <15 mL/min
- Known non-cardiovascular disease associated with poor prognosis (e.g. metastatic cancer)
- History of known hypersensitivity to rivaroxaban, aspirin or excipients
- Presence of contraindications to rivaroxaban and/or aspirin (as indicated in the technical data sheet)
Show all 9Show fewer
- Systemic treatment with strong inhibitors of CYP 3A4 or p-glycoprotein (e.g. systemic antifungals, such as ketoconazole and human immunodeficiency virus [HIV] protease inhibitors, such as ritonavir) or strong inducers of CYP 3A4, e.g. Rifampicin, Rifabutin, Phenobarbital, Phenytoin and Carbamazepine
- Any liver disease associated with coagulopathy
- Subjects who are pregnant, breastfeeding or potentially pregnant, or of childbearing age, sexually active and not practicing an effective method of birth prevention (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, patch contraceptive, sterilization of the male partner)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri
Milan
Laura Adelaide Dalla Vecchia, MD, +390250725120, laura.dallavecchia@icsmaugeri.it
About this study
Official title: PRospective Observational Study on PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)
The observational, prospective, multicenter study enrolls patients experiencing symptomatic peripheral atherosclerotic disease in the lower limb, with or without chronic ischemic heart disease, and who have an indication for treatment with rivaroxaban 2.5 mg twice daily and ASA 100 mg. The study's objective is to assess adherence to the prescribed treatment after 3 months and 12 months from enrollment, as well as to monitor any adverse events that may occur during this period.
Read the detailed description
Life expectancy in patients suffering from chronic peripheral obstructive arterial disease is significantly reduced compared to their non-arteriopathic peers. Mortality 15 years after diagnosis of ACOP is approximately 70%. Literature studies showed that treatment with rivaroxaban 5 mg bid, compared to acetylsalicylic acid (ASA), caused a significant increase in bleeding, in the absence of a clear clinical benefit. Instead, the rivaroxaban 2.5bid-ASA combination strategy proved to be more effective than ASA monotherapy, in terms of a 24% reduction in the combined primary endpoint (cardiovascular death, myocardial infarction, stroke). On the basis of these results, the recent guidelines of the European Society of Cardiology on chronic coronary syndromes recommend, in secondary prevention, the addition of a second antithrombotic drug to ASA in patients with high (recommendation class IIa, level of evidence A) or moderate (class of recommendation IIb, level of evidence A) risk of ischemic events, in the absence of high bleeding risk. The choice of drug to combine with ASA falls on a P2Y12 platelet receptor inhibitor or an anticoagulant, i.e. rivaroxaban 2.5 mg.
However, the use of the association of an antiplatelet drug with a low-dose anticoagulant drug and adherence to this treatment has not yet been adequately evaluated in the real world. In fact, no Italian observational data relating to this therapeutic strategy are currently available.
The observational, prospective, multicenter study includes patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and ASA 100 mg. The aim of the study is to examine the adherence to the treatment prescriptions after 3 months and after 12 months the enrolment and possible adverse events occurred in this time period.
- Conditions
- Peripheral Atherosclerotic Disease
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Observation for 1 year of patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the prescribed medical treatment
Adherence to the prescribed medical treatment measured by the Morisky Medication. Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.
Measured: 3 months
Adherence to the prescribed medical treatment
Adherence to the prescribed medical treatment measured by the Morisky Medication Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.
Measured: 12 months
Secondary outcomes (2)
Adverse event
Cardiovascular events, death
Measured: 3 months
Adverse event
Cardiovascular events, death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start31 Mar 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Atherosclerotic DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana Cardiologia Ospedalità Accreditata
- Responsible party
- Principal investigator, Laura Adelaide Dalla Vecchia, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239415
- Sponsor's protocol ID
- 2605CE
- Acronym
- PRO-PAS
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Observational Study on PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)
- ClinicalTrials.gov ID
- NCT06239415
- Acronym / sponsor ID
- PRO-PAS / 2605CE
- Conditions
- Peripheral Atherosclerotic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Società Italiana Cardiologia Ospedalità Accreditata
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
The observational, prospective, multicenter study enrolls patients experiencing symptomatic peripheral atherosclerotic disease in the lower limb, with or without chronic ischemic heart disease, and who have an indication for treatment with rivaroxaban 2.5 mg twice daily and ASA 100 mg. The study's objective is to assess adherence to the prescribed treatment after 3 months and 12 months from enrollment, as well as to monitor any adverse events that may occur during this period.
Detailed description
Life expectancy in patients suffering from chronic peripheral obstructive arterial disease is significantly reduced compared to their non-arteriopathic peers. Mortality 15 years after diagnosis of ACOP is approximately 70%. Literature studies showed that treatment with rivaroxaban 5 mg bid, compared to acetylsalicylic acid (ASA), caused a significant increase in bleeding, in the absence of a clear clinical benefit. Instead, the rivaroxaban 2.5bid-ASA combination strategy proved to be more effective than ASA monotherapy, in terms of a 24% reduction in the combined primary endpoint (cardiovascular death, myocardial infarction, stroke). On the basis of these results, the recent guidelines of the European Society of Cardiology on chronic coronary syndromes recommend, in secondary prevention, the addition of a second antithrombotic drug to ASA in patients with high (recommendation class IIa, level of evidence A) or moderate (class of recommendation IIb, level of evidence A) risk of ischemic events, in the absence of high bleeding risk. The choice of drug to combine with ASA falls on a P2Y12 platelet receptor inhibitor or an anticoagulant, i.e. rivaroxaban 2.5 mg.
However, the use of the association of an antiplatelet drug with a low-dose anticoagulant drug and adherence to this treatment has not yet been adequately evaluated in the real world. In fact, no Italian observational data relating to this therapeutic strategy are currently available.
The observational, prospective, multicenter study includes patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and ASA 100 mg. The aim of the study is to examine the adherence to the treatment prescriptions after 3 months and after 12 months the enrolment and possible adverse events occurred in this time period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg
Key inclusion criteria (2 listed)
- Patients with symptomatic peripheral atherosclerotic disease of the lower extremity
- Ability to provide written informed consent.
Key exclusion criteria (9 listed)
- Need for dual antiplatelet therapy, or therapy with antiplatelet agents other than aspirin or oral anticoagulant therapy (full dose)
- Ischemic stroke within the previous 1 month or any history of hemorrhagic or lacunar stroke
- Dialysis or estimated glomerular filtration rate <15 mL/min
- Known non-cardiovascular disease associated with poor prognosis (e.g. metastatic cancer)
- History of known hypersensitivity to rivaroxaban, aspirin or excipients
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 |
|---|---|---|
| observationObservation for 1 year of patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg. | Other | – |
Primary outcome
Adherence to the prescribed medical treatment
Time frame: 3 months
Adherence to the prescribed medical treatment measured by the Morisky Medication. Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.
Adherence to the prescribed medical treatment
Time frame: 12 months
Adherence to the prescribed medical treatment measured by the Morisky Medication Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.
2 secondary outcomes
Adverse event
Time frame: 3 months
Adverse event
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Atherosclerotic Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Adelaide Dalla Vecchia, MD (+390250725120, laura.dallavecchia@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the prescribed medical treatment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.