NIPH Clinical Trials Search

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Acute Ischemic Stroke
Date of first enrollment	18/02/2026
Target sample size	740
Countries of recruitment	China,Japan,United States,Japan,Finland,Japan,Spain,Japan,Italy,Japan,Bulgaria,Japan,Germany,Japan,Poland,Japan,Belgium,Japan,Canada,Japan,Greece,Japan,Latvia,Japan,Lithuania,Japan,Malaysia,Japan,Portugal,Japan,Serbia,Japan,South Korea,Japan,Thailand,Japan,Hungary,Japan,France,Japan
Study type	Interventional
Intervention(s)	Experimental: Part 1 - JX10 (1mg/kg) Drug: JX10 Experimental: Part 1 - JX10 (3mg/kg) Drug: JX10 Placebo Comparator: Part 1 - Placebo Drug: Placebo Experimental: JX10 Part 2 - (1 or 3 mg/kg) Drug: JX10 Placebo Comparator: Part 2 - Placebo Drug: Placebo

Outcome(s)

Primary Outcome	Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization
Secondary Outcome	Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days Proportion of participants with functional independence at 90 days -mRS score 0-2 Incidence of adverse events (AEs) and serious adverse events (SAEs) Incidence of major bleeding within 24 hours and 14 days of study treatment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 90age old
Gender	Both
Include criteria	1. Age >= 18 and =< 90 years old. 2. Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA). 3. Radiographic evidence of salvageable tissue. 4. Pre-treatment score of NIHSS >= 5.
Exclude criteria	1. Radiographic findings pre-randomization of any of the following: a. Large core infarction, or b. Occlusion in more than 1 vascular territory, or c. Significant mass effect or clinically significant cerebral edema, or d. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation, or e. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic. 2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding. 3. Severe, uncontrolled hypertension (systolic blood pressure >= 185 mmHg or diastolic blood pressure >= 110 mmHg) that can not be controlled with antihypertensive therapy. 4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000/uL, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds. 5. Major trauma, surgery, or invasive procedures. 6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study. 7. Pre-treatment blood glucose > 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose < 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.