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
试验速览
- 阶段
- 不适用
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- frequency of patients treated after PCI with each drug class.
研究概览
简要总结
This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile)
- •Lactation
- •No health insurance
- •Prisoners
结局指标
主要结局
frequency of patients treated after PCI with each drug class.
时间窗: 1 year
次要结局
- tthe type of bleeding events according TIMI classification1 for each drug(18 MONTHS)
- The major adverse cardiovascular events (MACE)(18 months)
- 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)