New stroke drug enters early safety testing
NCT ID NCT07513233
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This early-stage study tests whether a drug called anisodine hydrobromide is safe for people having a stroke caused by a blocked large artery in the brain. About 92 adults aged 18 to 80 who are already scheduled for a clot-removal procedure will receive the drug. The main goal is to check for serious side effects like bleeding in the brain or death within 8 days of treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anji County People's Hospital
Huzhou, Zhejiang, 313300, China
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Jiuquan City People's Hospital
Jiuquan, Gansu, 735000, China
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Taizhou Enze Medical Center (Group) Enze Hospital
Taizhou, Zhejiang, 318053, China
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
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The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100, China
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The Second People's Hospital of Yulin
Yulin, Guangxi, 537000, China
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Xuanwu Hospital, Capital Medical University
Beijing, None Selected, 100053, China
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Yueqing People's Hospital
Yueqing, Zhejiang, 325600, China
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Zhangpu County Hospital
Zhangzhou, Fujian, 363200, China
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Zibo Central Hospital
Zibo, Shandong, 255036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better