Evaluation De L'incidence Des Évènements Hémorragiques Et Ischémiques En Post-angioplastie Chez Des Patients Coronariens Anticoagulés Dans Le Cadre D'une Fibrillation Auriculaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2
研究概览
简要总结
Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose.
In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation
- •Patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is in a period of exclusion determined by a previous study
- •The patient has already been included into this study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient pregnant, parturient or breast feeding
结局指标
主要结局
Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2
时间窗: Month 12
Number of patients
次要结局
- Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2(Month 6)
- Occurrence of stroke(Month 12)
- Occurrence of stent thrombosis(Month 12)
- Extrinsic imputability of hemorrhagic eccent(Month 12)
- Platelet aggregation test(Month 12)
- Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement(Month 12)
- Occurrence of revascularization of the target lesion without death(Month 12)
- Stroke risk(Month 12)
- Extrinsic imputability of transient ischemic attack(Month 12)
- Intrinsic imputability of hemorrhagic eccent(Month 12)
- Number of anti-platelet aggregations taken(Month 12)
- Fibrin monomers level(Month 12)
- Occurrence of peripheral embolism(Month 12)
- Duration of triple therapy(Month 12)
- Compliance with antiplatelet and anticoagulant therapy(Month 12)
- Thrombin generation test(Month 12)
- Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)(Month 12)
- International Normalized Ratio (INR) for patients under if anti-vitamin K therapy(Month 12)
- D-dimers level(Month 12)
- Concordance rate between the drug compliance score and the biological assessment(Month 12)
- Bleeding Academic Research Consortium Score(Month 12)
- Occurrence of myocardial infarction(Month 12)
- Occurrence of death from any cause(Month 12)
- Intrinsic imputability of transient ischemic attack(Month 12)
- Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants(Month 12)
- Dose of anti-platelet aggregation and the anticoagulants(Month 12)
- Global drug compliance(Month 12)