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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00325-52 | Registry Identifier | APHM |
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This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual therapy | including 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| an observational study | Other | this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description. |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of patients treated after PCI with each drug class. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The type, the daily dosage and the duration of each drug class | 18 MONTHS | |
| The type, the daily dosage and the duration of each drug combination | 18 MONTHS | |
| tthe type of bleeding events according TIMI classification1 for each drug |
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Inclusion Criteria:
The eligible subjects must meet all of the following criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pr Laurent BONELLO | Contact | +33(0)4 91 96 86 83 | laurent.bonello@ap-hm.fr | |
| Alexandra Giuliani | Contact | 04 91 38 28 70 | promotion.interne@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | 13354 | France |
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| 18 MONTHS |
| The major adverse cardiovascular events (MACE) | 18 months |