At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised Trial of Tenecteplase vs. Alteplase for Recanalisation in Acute Ischemic Stroke
In Brief
A Phase 3 clinical trial evaluating Tenecteplase and Alteplase for Ischemic Stroke. Completed, enrolled 1,050 participants across 13 sites.
Detailed 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).
Study Details
Timeline
Interventions
0.4 mg/kg single bolus intravenously
0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously