None listed
Conditions
Interventions
150-325 mg aspirin will be given as soon as possible. An intravenous heparin bolus of 5000U will be given followed by a continuous intravenous infusion of 1000U/h for patients >80kg and 800U/h for patients
150-325 mg of aspirin will be administered as soon as possible. A bolus of intravenous Hirulog 0.25mg/kg followed by a Hirulog infusion of 0.5mg/kg/hour, for 12 hours, and then 0.25mg/kg/hour of Hirulog for at least 36 hours and up to 48 hours. As soon as practicable after the Hirulog bolus and simultaneously with the start of the Hirulog infusion, 1.5MU of intravenous streptokinase will be delivered for 30-60minutes. If there are problems due to lack of intravenous access, the Hirulog infusion,
Sponsors
THE MEDICINES COMPANY, CAMBRIDGE M.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients of any age with symptoms of acute myocardial infarction lasting more than 30 minutes and requesting medical support during the first 6 hours, and that have been shown to have at least 1mm of segment elevation are considered candidates for this study. ST in two or more leads of the precordial limbs or leads (V4-V6) or at least 2mm of ST-segment elevation in 2 or more contiguous precordial leads (V1-V3) in a 12-lead electrocardiogram, or the development of a new left branch block.
Exclusion criteria
Exclusion criteria: - Active bleeding or known hemorrhagic diathesis. - History of CVA, dementia or damage to the central nervous system (for example neoplasia, aneurysm, arteriovenous malformation, intracranial or intraspinal surgery or trauma), or transient ischemic attacks within the previous six months. - Major surgery or significant trauma in the past six weeks. - Gastrointestinal bleeding within the past six weeks, - Vascular puncture not compressible within the previous two weeks. - Severe hypertension uncontrollable upon admission (blood pressure> 180 / 110mm Hg) - Concomitant use of oral anticoagulants - Previous administration of streptokinase - Use of any investigational drug in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Mortality from all causes in patients with acute myocardial infarction who are candidates for thrombolytic therapy. Measure:Primary effectiveness criteria Timepoints:30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Net clinical benefit (absence of death and non-fatal disabling stroke) Measure:Secondary effectiveness criteria Timepoints:30 days ; Outcome name:Non-fatal reinfarction during index hospitalization. Measure:Secondary effectiveness criteria Timepoints:30 days ; Outcome name:Occurrence of adverse clinical events and laboratory abnormalities. Measure:Safety criteria Timepoints:Throughout the study. ; Outcome name:Combined reinfarction (intrahospital) and mortality Measure:Secondary effectiveness criteria Timepoints:30 days | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, United Kindgdom, United States
Outcome results
None listed