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.
An additional 1,000 patients will be randomized into a satellite study, ASSENT 3 Plus
, investigating pre-hospital administration of either TNKase with enoxaparin sodium or TNKase with heparin sodium.