Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (H… (NCT07513233) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)
China92 participantsStarted 2026-04-15
Plain-language summary
This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 80 years.
* Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1 segment, or the proximal M2 segment or a dominant M2 branch. A dominant M2 branch was defined as an M2 branch supplying ≥50% of the middle cerebral artery territory.
* Eligible for and planned to undergo endovascular treatment (EVT) within 24 hours according to current clinical practice.
* National Institutes of Health Stroke Scale (NIHSS) score ≥6 at baseline.
* Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline noncontrast CT.
* Pre-stroke modified Rankin Scale (mRS) score of 0 to 1.
* Provision of written informed consent by the participant or the participant's legally authorized representative.
Exclusion Criteria:
* Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
* History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant hemorrhagic conditions.
* Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons.
* Known allergy to iodinated contrast agents.
* Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment.
* Known hyper…
What they're measuring
1
Incidence of Predefined Safety Events
Timeframe: Within 8 days after the first administration