Evaluation of a modified Anti-Platelet Therapy associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy (TARGET-FIRST)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 695
- 试验地点
- 12
- 主要终点
- Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).
研究概览
简要总结
The primary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy, in reaching non-inferior NACCE (among clinically stable, low to moderate complexity acute MI patients).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days
- •Subject is eligible for per-protocol antiplatelet treatments
- •Written informed consent
- •Angiographic criteria: successful revascularization in native coronary arteries only, in vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm, implanted with the study device, with a maximum of 3 lesions treated and maximum total stent length ≤ 80 mm
- •Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure.
排除标准
- •Subjects with prior STEMI or prior PCI within 12 months before index admission
- •Participation in another interventional clinical trial
- •Angiographic criteria: In-stent restenosis or thrombosis Chronic total occlusion, or Severe calcification, or True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents, or Left main coronary artery lesion, or Residual untreated dissection ≥ C, or Implantation of a non-study stent
- •Subject is deemed to receive preferentially CABG within 1 year
- •Prior Coronary Artery Bypass Graft (CABG) Surgery, Prior stent thrombosis, Ischemic stroke or ICH within 12 months
- •Cardiogenic shock, Secondary PCI, Fibrinolysis
- •Planned PCI, CABG, or surgery within 12 months
- •Need for Oral Anti-Coagulation therapy
- •eGFR <30 mL/min/1.73 m2 or dialysis
- •Active bleeding at time of inclusion or high risk for major bleeding (History of bleeding diathesis or coagulopathy or subject refuse blood transfusions, Stage B or C liver cirrhosis or active cancer within 12 months prior to index procedure, Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure, Moderate or severe thrombocytopenia)
- •Expected non-adherence to study protocol
- •Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds
结局指标
主要结局
Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).
Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).
次要结局
- The main secondary endpoint is BARC type 2, 3 or 5 bleeding events at 11 months post-randomization.
研究者
Clinical Affairs
Scientific
SORIN CRM SAS (Microport CRM)