Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke
Status:
Completed
Trial end date:
2016-12-31
Target enrollment:
Participant gender:
Summary
BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only
approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase
is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening
of the vessel and up to 40% of the patients may remain severely disabled or die, leaving
substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be
more effective and may have less bleeding complications than alteplase, and may be the drug
of choice also in stroke.
HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose
that is associated with improved clinical outcome compared with existing treatment options.
AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after
symptom onset.
STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months
(effect). Secondary study endpoints are major early clinical improvement (effect) and
bleeding complications (safety).