EUCTR2016-001642-26-ES进行中（未招募）1 期
STREAM-2 (STrategic Reperfusion in elderly patients Early After Myocardial Infarction) - STREAM-2
euven Research & Development (LRD) at University of Leuven, Belgium0 个研究点目标入组 600 人开始时间: 2017年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age equal or greater than 70 years
- •2.Onset of symptoms < 3 hours prior to randomisation
- •3.12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):
- •* >=2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of >= 4 mm ST-elevation
- •* >=2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of >= 4 mm ST-elevation
- •4.Informed consent received
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1.Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
- •2.Previous CABG
- •3.Left bundle branch block or ventricular pacing
- •4.Patients with cardiogenic shock - Killip Class 4
- •5.Patients with a body weight < 55 kg (known or estimated)
- •6.Uncontrolled hypertension, defined as sustained blood pressure >= 180/110 mm Hg (systolic BP >= 180 mm Hg and/or diastolic BP >= 110 mm Hg) prior to randomisation
- •7.Known prior stroke or TIA
- •8.Recent administration of any i.v. or s.c. anticoagulation within 12 hours, including unfractionated heparin, enoxaparin, and/or bivalirudin or current use of oral anticoagulation (i.e. warfarin or a NOACs)
- •9.Active bleeding or known bleeding disorder/diathesis
- •10.Known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months)
- •11.Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction)
- •12.Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
- •13.Known severe renal insufficiency
- •14.Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
- •15.Known acute pericarditis and/or subacute bacterial endocarditis
- •16.Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •17.Dementia
- •18.Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- •19.Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
- •20.Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
研究者
相似试验
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STrategic Reperfusion in Elderly Patients Early After Myocardial InfarctionMyocardial InfarctionNCT02777580KU Leuven609
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STREAM - STrategic Reperfusion Early After Myocardial InfarctionComparison of the efficacy and safety of a strategy of pre-hospital fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms - STREAMST-elevation myocardial infaction within 3 hours of onset of symptomsMedDRA version: 9.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionEUCTR2007-001219-44-BESCS Boehringer Ingelheim Comm.V2,000
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STREAM - STrategic Reperfusion Early After Myocardial InfarctionComparison of the efficacy and safety of a strategy of pre-hospital fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms - STREAMST-elevation myocardial infaction within 3 hours of onset of symptomsMedDRA version: 9.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionEUCTR2007-001219-44-FRBoehringer Ingelheim France2,000
进行中（未招募）
不适用
STREAM - STrategic Reperfusion Early After Myocardial InfarctionComparison of the efficacy and safety of a strategy of early fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms - STREAMEUCTR2007-001219-44-DEBoehringer Ingelheim Pharma GmbH & Co. KG2,000
进行中（未招募）
1 期
STREAM - STrategic Reperfusion Early After Myocardial InfarctionComparison of the efficacy and safety of a strategy of pre-hospital fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptomsComparación de la eficacia y seguridad de una estrategia de tratamiento fibrinolítico prehospitalario con tenecteplasa y tratamiento adicional con fármacos antiagregantes plaquetarios y antitrombóticos, seguido de cateterismo en las siguientes 6-24 horas o intervención coronaria de rescate, frente a una estrategia de ICP primaria estándar en pacientes con infarto agudo de miocardio tratados en las 3 horas siguientes al inicio de los síntomas STREAM (STrategic Reperfusion Early After Myocardial Infarction; Reperfusión precoz estratégica tras el infarto de miocardio) - STREAMST-elevation myocardial infaction within 3 hours of onset of symptomsInfarto de miocardio con elevación ST en las tres horas siguientes al inicio de los síntomas.MedDRA version: 9.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionEUCTR2007-001219-44-ESBoehringer Ingelheim España, S.A.2,000