Prospective Real-world Registry Describing Treatment Regimens
NCT ID: NCT03942913
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
573 participants
OBSERVATIONAL
2019-10-10
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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dual therapy
including 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC.
an observational study
this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
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.
an observational study
this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
Interventions
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an observational study
this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* Lactation
* No health insurance
* Prisoners
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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bonello laurent
Role: primary
Other Identifiers
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2019-A00325-52
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-20
Identifier Type: -
Identifier Source: org_study_id
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