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NCT07513233Active, not recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
92 (estimated)
First submitted
29 Mar 2026
Start date
28 Apr 2026
Primary completion date
20 Nov 2026
Lead sponsor
Capital Medical University
Diseases
Stroke
NCT number
NCT07513233

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 92
  • From 28 Apr 2026 to the primary completion date, 20 Nov 2026
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known hypersensitivity to anisodine hydrobromide or a history of severe intolerance after prior exposure.
  • Participation in another interventional clinical study within 30 days before enrollment, or current participation in another interventional clinical study.

Other illness

  • 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.
  • Known allergy to iodinated contrast agents.
  • 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.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Other

  • Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons.
  • Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Anji County People's Hospital
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HuzhouChinaUnknown status
Jiuquan City People's Hospital
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JiuquanChinaUnknown status
The First People's Hospital of Shangqiu
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ShangqiuChinaUnknown status
Taizhou Enze Medical Center (Group), Enze Hospital
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TaizhouChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Yueqing People's Hospital
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YueqingChinaUnknown status
The Second People's Hospital of Yulin
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YulinChinaUnknown status
Zhangpu County Hospital
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ZhangzhouChinaUnknown status
Zibo Central hospital
Coordinator of this site? Confirm its status
ZiboChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.