Myocardial Infarction Clinical Trial
Official title:
STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early 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
This study aims at evaluating, in a proof of concept approach, the outcome of patients
presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in
either a pre-hospital setting or community hospital emergency room without a PCI facility.
Following randomisation a strategy of early tenecteplase and additional antiplatelet and
antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary
intervention as appropriate (or by rescue coronary intervention if required) in Group A will
be compared to primary PCI performed according to local standards in Group B.
The study is exploratory in nature and will examine this medical question. The efficacy and
safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before
30 days following randomisation will be evaluated.
All clinical endpoints of main interest will be assessed as single or composite endpoints for
evaluation of the trial objective. All statistical tests are of exploratory nature based on
descriptive p-values for formal statistical hypotheses generation.
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