EUCTR2007-001219-44-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ST-elevation myocardial infaction within 3 hours of onset of symptoms
- Sponsor
- Boehringer Ingelheim France
- Enrollment
- 2000
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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Not Applicable
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