Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis
Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,799
Ticagrelor, 180 mg as early as possible after the index event and not \>24 h post event followed by 90 mg twice daily for 12 months.
300 mg clopidogrel as early as possible after the index event and not \> 24h post event, followed by 75mg/day for 12 months. For patients with \> 75 years the recommended load dose is 75 mg instead 300 mg.
Safety Outcome as a measure of Time to TIMI-defined first major bleeding
The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding). Bleeding TIMI Definition Major: Any intracranial hemorrhage (ICH)\*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥ 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of ≥ 15%). An independent blinded central adjudication committee will adjudicate all suspected primary end points.
Time frame: 30 days
Efficacy Outcome as a measure of major cardiovascular events
Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event. We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.
Time frame: 12 months
Safety Outcome as a measure of bleeding event
Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests
Time frame: 12 months
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