Optimizing Reperfusion to Improve Outcomes and Neurologic Function
NCT ID: NCT06990867
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
740 participants
INTERVENTIONAL
2025-05-15
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
NCT05965687
Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke
NCT06202378
Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy
NCT05700097
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
NCT05604638
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
NCT01955707
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1 - JX10 (1mg/kg)
JX10
JX10 is a thrombolytic agent.
Part 1 - JX10 (3mg/kg)
JX10
JX10 is a thrombolytic agent.
Part 1 - Placebo
Placebo
Placebo is being used as the comparator.
JX10 Part 2 - (1 or 3 mg/kg)
JX10
JX10 is a thrombolytic agent.
Part 2 - Placebo
Placebo
Placebo is being used as the comparator.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JX10
JX10 is a thrombolytic agent.
Placebo
Placebo is being used as the comparator.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
1. Large core infarction, or
2. Occlusion in more than 1 vascular territory, or
3. Significant mass effect or clinically significant cerebral edema, or
4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
5. 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 cannot be controlled with antihypertensive therapy.
4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count \< 100,000/μL, 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.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corxel Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Senior Director, Clinical Operations
Role: STUDY_DIRECTOR
Corxel Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Corxel Investigational Site
Long Beach, California, United States
Corxel Investigational Site
Chicago, Illinois, United States
Corxel Investigational Site
Wichita, Kansas, United States
Corxel Investigational Site
Baltimore, Maryland, United States
Corxel Investigational Site
Kalamazoo, Michigan, United States
Corxel Investigational Site
Toledo, Ohio, United States
Corxel Investigational Site
Tulsa, Oklahoma, United States
Corxel Investigational Site
Dallas, Texas, United States
Corxel Investigational Site
Houston, Texas, United States
Corxel Investigational Site
Blagoevgrad, , Bulgaria
Corxel Investigational Site
Edmonton, , Canada
Corxel Investigational Site
Baotou, , China
Corxel Investigational Site
Beijing, , China
Corxel Investigational Site
Beijing, , China
Corxel Investigational Site
Changchun, , China
Corxel Investigational Site
Guangzhou, , China
Corxel Investigational Site,
Harbin, , China
Corxel Investigational Site
Harbin, , China
Corxel Investigational Site
Kaili, , China
Corxel Investigational Site
Linfen, , China
Corxel Investigational Site
Shanghai, , China
Corxel Investigational Site
Shenyang, , China
Corxel Investigational Site
Suzhou, , China
Corxel Investigational Site
Weifang, , China
Corxel Investigational Site
Xuzhou, , China
Corxel Investigational Site
Altenburg, , Germany
Corxel Investigational Site
Pavia, , Italy
Corxel Investigational Site
Roma, , Italy
Corxel Investigational Site
Yamagata, , Japan
Corxel Investigational Site
Kuching, , Malaysia
Corxel Investigational Site
Belgrade, , Serbia
Corxel Investigational Site
Kragujevac, , Serbia
Corxel Investigational Site
Seoul, , South Korea
Corxel Investigational Site
A Coruña, , Spain
Corxel Investigational Site
Barcelona, , Spain
Corxel Investigational Site
Girona, , Spain
Corxel Investigational Site
Madrid, , Spain
Corxel Investigational Site
Málaga, , Spain
Corxel Investigational Site
Valencia, , Spain
Corxel Investigational Site
Bangkok, , Thailand
Corxel Investigational Site
Khon Kaen, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Director
Role: primary
Study Director
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JX10002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.