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.
For the ASSENT II study, the administration of tenecteplase required the injection of a single bolus, which is definitely easier than the administration of alteplase, a drug that requires a 90 minute (accelerated) infusion.
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.
At one-year follow-up, tenecteplase, the single-bolus thrombolytic tested in the landmark ASSENT II clinical trial, has been found as efficacious as alteplase (Actilyse; Activase(R)) in saving the lives of heart attack patients.
Frans Van de Werf, who chaired the randomized, double-blind ASSENT II trial.
As with all thrombolytics, the most significant clinical adverse events that occurred in ASSENT II included intracranial hemorrhage and stroke.
Preliminary Phase III results of the ASSENT II (ASsessment of the Safety and Efficacy of a New Thrombolytic agent) trial, a 17,000-patient study, were presented in March of this year at the American College of Cardiology meeting.
With more than 1,000 sites in 29 countries, ASSENT II was designed as a randomized, double-blind, parallel group trial of a weight-adjusted, 30-50 mg single bolus of Tenecteplase versus the 90 minute accelerated infusion of Activase(R) (Alteplase, recombinant) in acute myocardial infarction (AMI) patients.
Boehringer Ingelheim, co-sponsor of the ASSENT II study, is Genentech's developmental collaborator for Tenecteplase and international marketing partner for Alteplase.