In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
609
Half dose Tenecteplase
300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography followed by PCI or CABG if required, rescue PCI if required
Successful Reperfusion
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Time frame: 30 min post angiogram/PCI
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
Time frame: 30 days
Total Stroke
Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Time frame: 30 days
Major Non-intrancranial Bleedings
Time frame: 30 days
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Primary PCI accoring to local standards
Liverpool Hospital - Cardiology Department
Liverpool, Australia
Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro
Campinas, Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Hospital Regional de Antofagasta
Antofagasta, Chile
Hospital Comunitario de Mejillones
Mejillones, Chile
Hospital de Melipilla
Melipilla, Chile
Hospital Regional de Rancagua
Rancagua, Chile
SAR Rancagua
Rancagua, Chile
Hospital San Juan de Dios
Santiago, Chile
Hospital de Talagante
Talagante, Chile
...and 40 more locations