The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
740
JX10 is a thrombolytic agent.
Placebo is being used as the comparator.
Corxel Investigational Site
Long Beach, California, United States
RECRUITINGCorxel Investigational Site
Sacramento, California, United States
RECRUITINGCorxel Investigational Site
Colorado Springs, Colorado, United States
RECRUITINGCorxel Investigational Site
Washington D.C., District of Columbia, United States
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days
Time frame: 90 days
Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization
Time frame: Within 36 hours post-randomization
Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days
Time frame: 90 days
Proportion of participants with functional independence at 90 days
Functional independence: mRS score 0-2
Time frame: 90 days
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 90 days
Incidence of major bleeding within 24 hours and 14 days of study treatment
Time frame: Within 24 hours and 14 days of study treatment
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Corxel Investigational Site
Delray Beach, Florida, United States
RECRUITINGCorxel Investigational Site
Chicago, Illinois, United States
RECRUITINGCorxel Investigational Site
Wichita, Kansas, United States
RECRUITINGCorxel Investigational Site
Baltimore, Maryland, United States
RECRUITINGCorxel Investigational Site
Kalamazoo, Michigan, United States
RECRUITINGCorxel Investigational Site
Traverse City, Michigan, United States
RECRUITING...and 73 more locations