What is the Purpose of this Study?
The purpose of the study is to evaluate whether an experimental drug called JX10 can safely help to restore blood flow for people who are having an acute ischemic stroke that present within 4.5 to 24 hours after the study participant was last known well or began experiencing AIS symptoms. JX10 works by breaking down clots that block the arteries and blocking inflammation. In Part 1 of the study, different doses of JX10 will be tested to identify which dose of the study drug (if any) may be the most effective and safe. In Part 2 of the study, the most effective and safe dose from Part 1 will be used to confirm the safety and effectiveness of that dose. In both parts of the study, participants may receive a placebo (inactive substance) instead of JX10
The study doctor will determine if patients may be eligible to participate in the study. Study procedures also include imaging and completion of questionnaires.
Eligibility
- 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.
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Inclusion 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.
Exclusion Criteria:
- 1. Radiographic findings pre-randomization of any of the following:
- 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.
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Optimizing Reperfusion to Improve Outcomes and Neurologic Function : A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke with Late Presentations