ASSENT 2

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ASSENT 2

Assessment of the Safety of a New Thrombolytic-2. A trial comparing efficacy and safety of tenecteplase to alteplase in patients with acute myocardial infarction.
Conclusion Both are equivalent.
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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.