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(Circulation. 2002;106:2986-a.)
© 2002 American Heart Association, Inc.

Late-Breaking Clinical Trial Abstracts

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Assessment of the Safety and Efficacy of a New Thrombolytic Regimen in the Prehospital Setting (ASSENT III Plus)
Lars Wallentin, Paul Armstrong, Chris Granger, Frans van de Werf, for the ASSENT-III PLUS investigators From the Departments of Cardiology, University Hospitals Uppsala, Sweden, Alberta Canada, Durham, USA, and Leuven, Belgium.

Background: The purpose was to evaluate the efficacy and safety of enoxaparin (ENOX) versus unfractionated heparin (UFH) added to tenecteplase in myocardial infarction in the prehospital setting concerning 30-day outcome and the time gain and outcome compared to in-hospital treatment in the previously reported ASSENT-III trial. Methods: Patients with chest pain <6 hours after symptom onset and demonstrating ST-elevation were randomized. The pre-hospital ASSENT-III PLUS trial recruited 1639 patients at 88 sites in 11 countries and was also compared with the 4038 patients in the ASSENT III trial. The designs were open label, parallel group trials with randomization to treatment with tenecteplase in combination with either ENOX given as an IV bolus 30 mg followed by s.c. 1 mg/kg every 12 hours until hospital discharge or 7 days, or UFH IV bolus 60 IU/kg followed by infusion 12 IU/kg/h with target APTT for 50–70 seconds. The primary efficacy end point was 30-day mortality, in-hospital reinfarction, or in-hospital refractory ischemia, and the primary efficacy and safety end point also added in-hospital intracranial hemorrhage (ICH) or in-hospital major bleeds.

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The excess of ICH in the ENOX group was only seen in patients aged >75 years and also explained the numerically higher mortality in that group. Compared with in-hospital, there was a 41 minutes time gain from symptom onset to treatment by . . . [Full Text of this Article]

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