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XY03-EA in Acute Ischemic Stroke
NCT05515393Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 2022
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Yiling Pharmaceutical
- Modality
- Small Molecules
- Drugs
- XY03-EA
- Conditions
- ischemic stroke
01
Overview
Phase 2, randomised, double-blind trial of XY03-EA in ischemic stroke (3 arms), sponsored by Yiling Pharmaceutical. Primary endpoint: Proportion of patients with Modified Rankin Scale (mRS) score <= 1 at 90 days. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
XY03-EA 300mg
XY03-EA 150mg x 2 + Placebo x 2, TID for 90 days
XY03-EA 600mg
XY03-EA 150mg x 4, TID for 90 days
Placebo
Placebo x 4, TID for 90 days
03
Who it enrols
Adult patients (18-80 years) with acute ischemic stroke within 48 hours of onset, NIHSS score 6-20, and pre-stroke mRS <= 1. Patients receiving rt-PA within 4.5 hours are eligible. Excludes patients with hemorrhagic stroke, severe consciousness disturbance, renal/liver insufficiency, uncontrolled blood pressure/glucose, or use of other neuroprotective drugs.
04
Endpoints
Primary
Proportion of patients with Modified Rankin Scale (mRS) score <= 1
Secondary
Proportion of patients with Modified Rankin Scale (mRS) score <= 2
Proportion of patients with Modified Rankin Scale (mRS) score <= 1 at interim points
Change in NIHSS score from baseline
Proportion of patients with NIHSS score <=1 or decrease >=4
Proportion of patients with Barthel Index (BI) >= 95
Change in MMSE score
Proportion of patients with new vascular events
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