One of the first non-inferiority trials in the therapeutic domain of thrombolytics for the treatment of acute MI patients was ASSENT II. (4,5) Specifically, ASSENT II compared the 30-day mortality rates of single-bolus tenecteplase (E) with accelerated infusion of alteplase (C).
This could not be assumed for tenecteplase at the time of the planning of the ASSENT II study, and hence a non-inferiority design seemed to be a solution.
The Duke team analyzed data from two large international, multicenter thrombolytic trials conducted six years apart: GUSTO-I, conducted from 1990 to 1993, involved 41,021 patients, and ASSENT II
, conducted from 1997 to 1998, involved 16,950 patients.