As with all thrombolytics, the most significant clinical adverse events that occurred in ASSENT II included intracranial hemorrhage and stroke.
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.
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.
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.