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Tenecteplase vs Alteplase in Acute Ischemic Stroke
NCT02180204Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jan 2015
- Primary completion
- Jun 2020
- Countries
- 1
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- tenecteplase
- Conditions
- ischemic stroke
01
Overview
Phase 3, randomised, double-blind trial of tenecteplase in ischemic stroke (2 arms). Primary endpoint: Neurological outcome at 90 days. Planned start Jan 2015; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tenecteplase
Tenecteplase 0.25 mg/kg IV
Alteplase
Alteplase 0.9 mg/kg IV
03
Who it enrols
Patients aged 18-80 with acute ischemic stroke (NIHSS >= 4) presenting within 3-4.5 hours of onset, without hemorrhage on CT, uncontrolled hypertension, or recent major surgery/trauma.
04
Endpoints
Primary
Neurological outcome
Secondary
Symptomatic intracranial hemorrhage
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