Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)

NCT07513233 | Recruiting Phase 1 DMC

• 1 other identifier: HEAL
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular Treatment; Neuroprotection; Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of Predefined Safety Events

  The primary safety outcome is the incidence of prespecified safety events occurring within 8 days after the first administration of the study drug. Prespecified safety events include: (1) symptomatic intracranial hemorrhage, defined as any intracranial hemorrhage confirmed on neuroimaging in conjunction with neurological deterioration, operationalized as an increase of at least 4 points in the NIHSS score; (2) death from any cause; and (3) any other serious adverse event, excluding the foregoing events, that is adjudicated by the Data Monitoring Committee (DMC) to be definitely, probably, or possibly related to the study drug.

  Within 8 days after the first administration

Secondary Outcomes (6)

• Early Neurological Deterioration

  Within 24 hours after treatment initiation

• Infarct Volume

  Day 8

• Functional Outcome (Modified Rankin Scale)

  Day 90

• Symptomatic Intracranial Hemorrhage

  Within 8 days after the first administration

• Intracranial Hemorrhage

  Within 8 days after the first administration

Study Arms (4)

Anisodine Hydrobromide 1.0 mg

EXPERIMENTAL

Participants receive anisodine hydrobromide 1.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes.

Drug: Anisodine Hydrobromide

Anisodine Hydrobromide 1.5 mg

EXPERIMENTAL

Participants receive anisodine hydrobromide 1.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes.

Drug: Anisodine Hydrobromide

Anisodine Hydrobromide 2.0 mg

EXPERIMENTAL

Participants receive anisodine hydrobromide 2.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes.

Drug: Anisodine Hydrobromide

Anisodine Hydrobromide 2.5 mg

EXPERIMENTAL

Participants receive anisodine hydrobromide 2.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes.

Drug: Anisodine Hydrobromide

Interventions

Anisodine Hydrobromide DRUG

Anisodine hydrobromide injection is administered intravenously in addition to standard endovascular therapy for acute ischemic stroke. The investigational drug is diluted in 250 mL of 0.9% sodium chloride solution and infused over approximately 60 minutes. Treatment is given twice daily (BID) for 7 consecutive days, with the first dose initiated prior to vascular recanalization. In this Phase Ib study, four dose levels (1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg per dose) are evaluated using a sequential, cohort-based dose-escalation design to assess safety, tolerability, and dose feasibility. All participants receive standard-of-care endovascular therapy according to current clinical guidelines, including mechanical thrombectomy and/or adjunctive procedures as clinically indicated.

Anisodine Hydrobromide 1.0 mg; Anisodine Hydrobromide 1.5 mg; Anisodine Hydrobromide 2.0 mg; Anisodine Hydrobromide 2.5 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 hypersensitivity to anisodine hydrobromide or a history of severe intolerance after prior exposure.
• Presence of clinical conditions that may be worsened by anticholinergic drugs, including but not limited to angle-closure glaucoma, urinary retention or benign prostatic hyperplasia with dysuria, or paralytic ileus.
• Severe arrhythmia or hemodynamic instability, including but not limited to tachyarrhythmia requiring cardioversion, recurrent syncope due to arrhythmia, vasopressor-dependent hypotension, or persistent hypotension.
• Severe psychiatric disorder, dementia, or impaired consciousness that would preclude informed consent or protocol-required follow-up.
• Malignant tumor or other severe systemic disease with an expected survival of less than 90 days.
• Participation in another interventional clinical study within 30 days before enrollment, or current participation in another interventional clinical study.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, None Selected, 100053, China

NOT YET RECRUITING

Anji County People's Hospital

Huzhou, Zhejiang, 313300, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

anisodine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xunming Ji, MD/PhD

CONTACT

01083198962; jixm@ccmu.edu.cn

Chuanjie Wu, MD

CONTACT

01083199439; wuchuanjie@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 7, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)