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) - STREAM

Boehringer Ingelheim España, S.A.0 sites2,000 target enrollmentMarch 25, 2008

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ST-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.
Sponsor: Boehringer Ingelheim España, S.A.
Enrollment: 2000
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

March 25, 2008

End Date

September 1, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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)