About this trial
This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (\>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age equal or greater than 18 years
"Symptom onset-randomization" time interval <12 hours
Predicted "diagnosis-pPCI" time interval equal or greater than 120 minutes
Predicted "admission-pPCI" time interval equal or greater than 60 minutes
Disqualifiers
Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint
Trial design
Parallel
Treatments tested in this trial
Single, weight-adjusted i.v. bolus of tenecteplase
DrugSingle, weight-adjusted i.v. bolus of tenecteplase in case of \>60 min in-hospital delay in PCI center
catheterisation
Procedure/SurgeryStandard primary PCI
Treatment groups
Trial outcomes
Primary outcomes
The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.
Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.
Secondary outcomes
Number of patients with all-cause mortality
Number of patients with cardiovascular mortality
Number of patients with non-fatal MI
Number of patients with hemorrhagic stroke
Sponsors and contacts
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