2024-515433-15-02招募中4 期
Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia (SCA-FA): A prospective multicenter study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Occurrence during the 2 years of follow-up of a bleeding event defined by a score ≥2 according to the BARC scale
研究概览
简要总结
To show that the introduction of an anticoagulant treatment in patients with ACS and de novo AF based on the data furnished by an implantable holter with remote monitoring is safer in terms of occurrence of hemorrhagic events than the systematic introduction of an anticoagulant treatment associated to DAPT based on the CHA2DS2-VASc score
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients, aged ≥
- •Hospitalization for acute coronary syndrome with or without ST segment elevation
- •Atrial fibrillation present at the time of patient arrival at the hospital or occurring at any time during hospitalization. Patient without any prior known history of arrhythmia.
- •Chads2vas SCORE ≥ 1 for men and ≥ 2 for women
- •Ablation of atrial fibrillation before enrollment in the study. The atrial fibrillation ablation can be spontaneous or obtained by treatment
- •Coronary angioplasty with stenting should be done during the hospitalization
排除标准
- •Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not
- •Atrial fibrillation still present at inclusion time
- •Patient already on anticoagulant therapy
- •Creatinine clearance < 30 ml per minute
- •Contraindications to anticoagulant therapy
- •Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit
结局指标
主要结局
Occurrence during the 2 years of follow-up of a bleeding event defined by a score ≥2 according to the BARC scale
Occurrence during the 2 years of follow-up of a bleeding event defined by a score ≥2 according to the BARC scale
次要结局
- Occurrence of an event defined by the MACCE indicator
- Occurrence of an ischemic event defined by the following composite indicator: death from cardiovascular causes, stroke or systemic embolism, non-fatal infarction and need for revascularization
研究者
Alice SERIS
Scientific
Centre Hospitalier De Pau
研究点 (15)
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