EUCTR2007-001219-44-DE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 - STREAM
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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 18 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) yes
- •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
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 a single blood pressure measurement >= 180/110 mm Hg (systolic BP >=180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation
- •7.Hospitalisation for cardiac reason within past 48 hours
- •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 (warfarin or coumadin)
- •9.Active bleeding or known bleeding disorder/diathesis
- •10.Any 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.Any known history of haemorrhagic stroke, ischaemic stroke or transient ischaemic attack (TIA), or stroke of unknown origin
- •13.Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks
- •14.Known acute pericarditis and/or subacute bacterial endocarditis
- •15.Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •16.Chronic dialysis or known renal insufficiency
- •17.Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
- •18.Arterial aneurysm and known arterial/venous malformation
- •19.Pregnancy or lactation or parturition within the previous 30 days; women of childbearing potential must have a negative urine pregnancy test, or use a medically accepted method of birth control
- •20.Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- •21.Known hypersensitivity to tenecteplase, alteplase, acetylsalicylic acid, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography
- •22.Inability to follow the informed consent procedure, incapacity to comprehend nature, impact, risks and consequences of participation in this clinical trial, as well as 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
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