.A.

Not Applicable

• Conditions: -I213 Acute transmural myocardial infarction of unspecified site; Acute transmural myocardial infarction of unspecified site; I213

• Registration Number: PER-003-98
• Lead Sponsor: THE MEDICINES COMPANY, CAMBRIDGE M.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1998-02-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Mortality from all causes in patients with acute myocardial infarction who are candidates for thrombolytic therapy.<br>Measure:Primary effectiveness criteria<br>Timepoints:30 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Net clinical benefit (absence of death and non-fatal disabling stroke)<br>Measure:Secondary effectiveness criteria<br>Timepoints:30 days<br>;<br>Outcome name:Non-fatal reinfarction during index hospitalization.<br>Measure:Secondary effectiveness criteria<br>Timepoints:30 days<br>;<br>Outcome name:Occurrence of adverse clinical events and laboratory abnormalities.<br>Measure:Safety criteria<br>Timepoints:Throughout the study.<br>;<br>Outcome name:Combined reinfarction (intrahospital) and mortality<br>Measure:Secondary effectiveness criteria<br>Timepoints:30 days<br>