Subject Under Anticoagulant
Conditions
Brief 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.
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.
Interventions
OTHERan 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.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
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
Exclusion criteria
* Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile) * Lactation * No health insurance * Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of patients treated after PCI with each drug class. | 1 year |
Secondary
| Measure | 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 | 18 MONTHS |
| The major adverse cardiovascular events (MACE) | 18 months |
Countries
France
Contacts
Primary ContactPr Laurent BONELLO
Backup ContactAlexandra Giuliani
Outcome results
None listed