EUCTR2007-001219-44-FR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 symptoms - STREAM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •>/= 3 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of >/=6 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 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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