Comparison 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

• Conditions: ST elevation myocardial infarction within 3 hours of onset of symtoms; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2007-001219-44-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-17
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

-Age equal or greater than 18 years -Onset of symptoms < 3 hours prior to randomisation -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 or >= 3 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of >= 6 mm ST-elevation -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

Exclusion Criteria

-Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours -Previous CABG -Left bundle branch block or ventricular pacing -Patients with cardiogenic shock (Killip Class 4) -Patients with a body weight < 55 kg (known or estimated) -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 -Hospitalisation for cardiac reason within past 48 hours -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 anti-coagulation (warfarin or coumadin) -Active bleeding or known bleeding disorder/diathesis -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) -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) -Any known history of haemorrhagic stroke, ischaemic stroke or transient ischaemic attack (TIA), or stroke of unknown origin -Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks -Known acute pericarditis and/or subacute bacterial endocarditis -Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis -Chronic dialysis or known renal insufficiency -Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk -Arterial aneurysm and known arterial/venous malformation -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 -Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days -Known hypersensitivity to tenecteplase, alteplase, acetylsalicylic acid, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography -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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified