Atrial FibrillationPRODOACNCT06239402
Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease
An observational study of Atrial Fibrillation, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Observation
- How many people
- 394 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2020to 28 Jul 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: Patient with non valvular atrial fibrillation with direct oral anticoagulants and antiplatelet therapy who underwent percutaneous coronary intervention in the previous 7 days
Who may be able to join
- Patient with non valvular atrial fibrillation with direct oral anticoagulants therapy
- Patient on antiplatelet therapy (acetylsalicylic acid and/or inhibitor of the P2Y12 platelet receptor)
- Patient hospitalized for percutaneous coronary intervention in the previous 7 days
- Age ≥18 years
- Estimated life expectancy ≥ 12 months
- Ability to give informed consent
Who cannot join
- Patients who have contraindications to direct oral anticoagulants therapy
- Patients who are indicated for direct oral anticoagulants therapy for reasons other than non valvular atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on the Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease (PRODOAC)
The study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy) and to analyze the outcomes of therapeutic decisions, focusing on mortality, hemorrhagic events, and ischemic events,
Read the detailed description
The combination of warfarin, aspirin, and clopidogrel represented the standard antithrombotic therapeutic strategy for patients with atrial fibrillation and suffering from acute coronary syndrome and/or undergoing percutaneous coronary intervention.
Current guidelines and clinical practice guides suggest the use of triple or dual antithrombotic therapy after a careful evaluation of the patient's hemorrhagic and thrombotic profile, without however providing indications with recommendation class I. It is not known what treatment regimens are prescribed in the real world, i.e. how clinicians behave in the absence of clear guidelines.
This observational study involves patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy), to describe the real-world prescription model used in clinical practice and to analyze the results of therapeutic choices in terms of mortality, hemorrhagic and ischemic events.
Patients are enrolled within 7 days from percutaneous coronary intervention during their hospitalization period. During the enrolment visit (i.e. baseline, T0), all patients undergo a detailed assessment of their medical history related to the recent hospitalization, laboratory blood analysis, and data related to their cardiovascular risk factors. Follow-up visits will be performed at three months (T3) and twelve months (T12). During the follow-up visit, any ischemic/bleeding events, therapeutic changes, and laboratory blood analysis will be recorded.
- Conditions
- Atrial Fibrillation
- Being tested
- Observation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of mortality, haemorrhagic and ischemic events in the studied population
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Incidence of major bleeding and clinically relevant non major bleeding
Measured: 3 months
Bleeding
Incidence of major bleeding and clinically relevant non major bleeding
Measured: 12 months
Secondary outcomes (2)
Adverse events
Cardiovascular events, death
Measured: 3 months
Adverse events
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 start28 Jul 2020
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 394 participants (actual)
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
- NCT06239402
- Sponsor's protocol ID
- 2365CE
- Acronym
- PRODOAC
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease (PRODOAC)
- ClinicalTrials.gov ID
- NCT06239402
- Acronym / sponsor ID
- PRODOAC / 2365CE
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Società Italiana Cardiologia Ospedalità Accreditata
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- 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 study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy) and to analyze the outcomes of therapeutic decisions, focusing on mortality, hemorrhagic events, and ischemic events,
Detailed description
The combination of warfarin, aspirin, and clopidogrel represented the standard antithrombotic therapeutic strategy for patients with atrial fibrillation and suffering from acute coronary syndrome and/or undergoing percutaneous coronary intervention.
Current guidelines and clinical practice guides suggest the use of triple or dual antithrombotic therapy after a careful evaluation of the patient's hemorrhagic and thrombotic profile, without however providing indications with recommendation class I. It is not known what treatment regimens are prescribed in the real world, i.e. how clinicians behave in the absence of clear guidelines.
This observational study involves patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy), to describe the real-world prescription model used in clinical practice and to analyze the results of therapeutic choices in terms of mortality, hemorrhagic and ischemic events.
Patients are enrolled within 7 days from percutaneous coronary intervention during their hospitalization period. During the enrolment visit (i.e. baseline, T0), all patients undergo a detailed assessment of their medical history related to the recent hospitalization, laboratory blood analysis, and data related to their cardiovascular risk factors. Follow-up visits will be performed at three months (T3) and twelve months (T12). During the follow-up visit, any ischemic/bleeding events, therapeutic changes, and laboratory blood analysis will be recorded.
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
- Patient with non valvular atrial fibrillation with direct oral anticoagulants and antiplatelet therapy who underwent percutaneous coronary intervention in the previous 7 days
Key inclusion criteria (6 listed)
- Patient with non valvular atrial fibrillation with direct oral anticoagulants therapy
- Patient on antiplatelet therapy (acetylsalicylic acid and/or inhibitor of the P2Y12 platelet receptor)
- Patient hospitalized for percutaneous coronary intervention in the previous 7 days
- Age ≥18 years
- Estimated life expectancy ≥ 12 months
Key exclusion criteria (2 listed)
- Patients who have contraindications to direct oral anticoagulants therapy
- Patients who are indicated for direct oral anticoagulants therapy for reasons other than non valvular atrial fibrillation
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 of mortality, haemorrhagic and ischemic events in the studied population | Other | – |
Primary outcome
Bleeding
Time frame: 3 months
Incidence of major bleeding and clinically relevant non major bleeding
Bleeding
Time frame: 12 months
Incidence of major bleeding and clinically relevant non major bleeding
2 secondary outcomes
Adverse events
Time frame: 3 months
Adverse events
Time frame: 12 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 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
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 Atrial Fibrillation, 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 6 inclusion and 2 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 20 Feb 2025. 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?
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?
Bleeding (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 20 Feb 2025.