Subject Under AnticoagulantPRAETORIANNCT03942913
Prospective Real-world Registry Describing Treatment Regimens
An observational study of Subject Under Anticoagulant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subject Under Anticoagulant
- What is being tested?
- an observational study
- How many people
- 573 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2019to 31 Dec 2023
- How long will I take part?
- 12 Months
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: The recruiting will be performed in emergency and cardiologic units by using a consecutive screening and enrollment strategy. Information obtained as part of routine care will be reviewed to determine eligibility for enrollment including 12 lead electrocardiograms and medical exam, cardiac biomarker and all means considered necessary for diagnosis of intermediate-risk and high-risk ACS. For all patients undergoing an invasive strategy and requiring chronic anticoagulant therapy for AF, the site will carefully review the inclusion and exclusion criteria described in the protocol to confirm the subject's eligibility.
Who may be able to join
- The eligible subjects must meet all of the following criteria:
- Man or woman 18 years old or over
- Subject requiring percutaneous coronary intervention according to physician's and with AF requiring chronic anticoagulation by dual therapy or triple therapy;
- Subject with pulmonary embolism risk score > 1 for men and ≥ 1 for women in CHA2DS2-VASc classification
- Subject having declare its non-opposition to study participation
Who cannot join
- Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile)
- Lactation
- No health insurance
- Prisoners
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
bonello laurent
About this study
Official title: Real-world Prospective Registry to Describe the Current Treatment Patterns With Oral Anticoagulant and Antiplatelet Agents Association in Patients With Atrial Fibrillation and Undergoing Percutaneous Coronary Intervention
This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
Read the detailed description
Coordinator of project has strong expertise in cardiovascular research and especially in ACS, PCI and antiplatelet therapy. The group led by pr Bonello has published several articles (appendix 3) including the VASP studies which have been presented at major cardiologic congresses (late breaking trials ACC 2007, AHA 2008, TCT 2011, EuroPCR 2010) including physicians and biologists. The group is composed of international experts in this research field (Pr Bonello, Pr Cuisset, Dr Barragan, Pr Lemesle). Additionally, coordinator center has a strong expertise in clinical research and a methodological support will be provided by the Clinical Research Platform of the AP-HM (responsible: Prof. Pascal Auquier, medical referent: Dr Karine Baumstarck).
The project brings together investigators that have been previously involved in many clinical studies in the field of ACS and PCI. In particular they have joined forces on multicenter trials leaded by the cardiology department of the Hôpital Universitaire Nord de Marseille (the VASP studies, the Early clinical trial) and they have regular meetings to share scientific data and research program design and advancement. There is a good capacity and ability of recruitment by the partner centers. The procedures to perform in this project are very simple and the disease is frequent. These are good criteria for the feasibility.
- Conditions
- Subject Under Anticoagulant
- Being tested
- an observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an observational studyOther
this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
| Study group | Role | What they receive |
|---|---|---|
| dual therapy | including 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC. Receives: Other: an observational study | |
| triple therapy | including 2 antiplatelet treatments (aspirin and clopidogrel) associated with 1 anticoagulant treatment VKA or NOAC.
In VKA class, 2 different drugs are commonly prescribed: warfarin and fluidinione. In NOAC class, 3 different drugs are commonly prescribed: rivaroxaban, apixaban, dabigatran. Receives: Other: an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of patients treated after PCI with each drug class.
Measured: 1 year
Secondary outcomes (4)
The type, the daily dosage and the duration of each drug class
Measured: 18 MONTHS
The type, the daily dosage and the duration of each drug combination
Measured: 18 MONTHS
tthe type of bleeding events according TIMI classification1 for each drug
Measured: 18 MONTHS
The major adverse cardiovascular events (MACE)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start10 Oct 2019
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subject Under AnticoagulantStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 573 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942913
- Sponsor's protocol ID
- 2019-20
- Other IDs
- 2019-A00325-52
- Acronym
- PRAETORIAN
- Status last verified
- Aug 2022
- First submitted
- 24 Apr 2019
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Prospective Registry to Describe the Current Treatment Patterns With Oral Anticoagulant and Antiplatelet Agents Association in Patients With Atrial Fibrillation and Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03942913
- Acronym / sponsor ID
- PRAETORIAN / 2019-20
- Conditions
- Subject Under Anticoagulant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 573 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 May 2019 (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 study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
Detailed description
Coordinator of project has strong expertise in cardiovascular research and especially in ACS, PCI and antiplatelet therapy. The group led by pr Bonello has published several articles (appendix 3) including the VASP studies which have been presented at major cardiologic congresses (late breaking trials ACC 2007, AHA 2008, TCT 2011, EuroPCR 2010) including physicians and biologists. The group is composed of international experts in this research field (Pr Bonello, Pr Cuisset, Dr Barragan, Pr Lemesle). Additionally, coordinator center has a strong expertise in clinical research and a methodological support will be provided by the Clinical Research Platform of the AP-HM (responsible: Prof. Pascal Auquier, medical referent: Dr Karine Baumstarck).
The project brings together investigators that have been previously involved in many clinical studies in the field of ACS and PCI. In particular they have joined forces on multicenter trials leaded by the cardiology department of the Hôpital Universitaire Nord de Marseille (the VASP studies, the Early clinical trial) and they have regular meetings to share scientific data and research program design and advancement. There is a good capacity and ability of recruitment by the partner centers. The procedures to perform in this project are very simple and the disease is frequent. These are good criteria for the feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual therapy | – | Other: an observational studyincluding 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC. |
| triple therapy | – | Other: an observational studyincluding 2 antiplatelet treatments (aspirin and clopidogrel) associated with 1 anticoagulant treatment VKA or NOAC. In VKA class, 2 different drugs are commonly prescribed: warfarin and fluidinione. In NOAC class, 3 different drugs are commonly prescribed: rivaroxaban, apixaban, dabigatran. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The recruiting will be performed in emergency and cardiologic units by using a consecutive screening and enrollment strategy. Information obtained as part of routine care will be reviewed to determine eligibility for enrollment including 12 lead electrocardiograms and medical exam, cardiac biomarker and all means considered necessary for diagnosis of intermediate-risk and high-risk ACS. For all patients undergoing an invasive strategy and requiring chronic anticoagulant therapy for AF, the site will carefully review the inclusion and exclusion criteria described in the protocol to confirm the subject's eligibility.
Key inclusion criteria (5 listed)
- Man or woman 18 years old or over
- Subject requiring percutaneous coronary intervention according to physician's and with AF requiring chronic anticoagulation by dual therapy or triple therapy;
- Subject with pulmonary embolism risk score > 1 for men and ≥ 1 for women in CHA2DS2-VASc classification
- Subject having declare its non-opposition to study participation
Key exclusion criteria (4 listed)
- Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile)
- Lactation
- No health insurance
- Prisoners
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 |
|---|---|---|
| an observational studythis study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description. | Other | dual therapy, triple therapy |
Primary outcome
frequency of patients treated after PCI with each drug class.
Time frame: 1 year
4 secondary outcomes
The type, the daily dosage and the duration of each drug class
Time frame: 18 MONTHS
The type, the daily dosage and the duration of each drug combination
Time frame: 18 MONTHS
tthe type of bleeding events according TIMI classification1 for each drug
Time frame: 18 MONTHS
The major adverse cardiovascular events (MACE)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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 Subject Under Anticoagulant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 5 inclusion and 4 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 16 Aug 2022. 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 France. 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 Pr Laurent BONELLO (+33(0)4 91 96 86 83, laurent.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of patients treated after PCI with each drug class. (time frame: 1 year). 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 16 Aug 2022.