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NCT Number: NCT07513233

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xuanwu Hospital, Capital Medical University, Beijing, None Selected, China

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About this study

This study is an investigator-initiated, prospective, multicenter Phase Ib clinical trial designed to evaluate the safety, tolerability, and dose feasibility of anisodine hydrobromide administered in patients with acute ischemic stroke undergoing endovascular therapy. The trial adopts an open-label, non-randomized, dose-escalation design to identify the maximum tolerated dose (MTD) and to determine the recommended Phase II dose (RP2D).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Predefined Safety Events

    Time frame: Within 8 days after the first administration

    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.

Secondary outcomes

  1. Early Neurological Deterioration

    Time frame: Within 24 hours after treatment initiation

    Early neurological deterioration is defined as a worsening in neurological status within 24 hours after the initiation of treatment. Neurological status is quantified using the National Institutes of Health Stroke Scale (NIHSS), a validated clinical instrument for assessing stroke severity. The total score of the NIHSS ranges from a minimum of 0 to a maximum of 42. On this scale, higher scores indicate greater neurological impairment and a worse clinical outcome, whereas a score of 0 represents the absence of detectable neurological deficits.

  2. Infarct Volume

    Time frame: Day 8

    Infarct volume measured on cranial computed tomography (CT) at Day 8, expressed in milliliters (mL).

  3. Functional Outcome (Modified Rankin Scale)

    Time frame: Day 90

    Functional outcome assessed using the modified Rankin Scale (mRS), reported as the distribution of scores ranging from 0 (no symptoms) to 6 (death).

  4. Symptomatic Intracranial Hemorrhage

    Time frame: Within 8 days after the first administration

    Incidence of symptomatic intracranial hemorrhage confirmed by imaging and associated with neurological deterioration (increase of ≥4 points in NIHSS).

  5. Intracranial Hemorrhage

    Time frame: Within 8 days after the first administration

    Incidence of any intracranial hemorrhage detected by imaging within 8 days after the first administration.

  6. All-cause Mortality

    Time frame: Within 90 days after the first administration

    All-cause mortality occurring within 90 days after the first administration of the investigational drug.

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanjie Wu, MD

CONTACT

[email protected]

01083199439

Xunming Ji, MD/PhD

CONTACT

[email protected]

01083198962

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Safety and Efficacy of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment

Acronym: HEAL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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