ASSENT 3 PLUS

Assessment of the Safety of a New Thrombolytic-3 Plus. A clinical trial comparing enoxaparin and unfractionated heparin in prehospital management of acute myocardial infarction; ASSENT 3 PLUS failed to meet its primary outcome.

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Genentech (NYSE:DNA) has announced that results from the ASSENT 3 PLUS trial demonstrate pre-hospital administration of the single-bolus thrombolytic (clot-dissolving) agent TNKase(TM) (Tenecteplase) to patients suffering from acute myocardial infarction (AMI, or heart attack) to be technically feasible and faster than in-hospital treatment.

The 1,639-patient, international, multicenter, randomized, open-label ASSENT 3 PLUS clinical trial was a satellite study of the larger hospital-based ASSENT 3 trial.

Lars Wallentin, Uppsala University, Uppsala, Sweden, and principal investigator of the ASSENT 3 PLUS study.

ASSENT 3 PLUS was a descriptive study with two main, pre-specified composite endpoints: a composite efficacy endpoint to evaluate efficacy outcomes, and an "efficacy plus safety" composite endpoint to evaluate efficacy improvements when safety adverse events were added to the analysis.