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
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Anji County People's Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Jiuquan City People's Hospital Coordinator of this site? Confirm its status | Jiuquan | China | Unknown status |
| The First People's Hospital of Shangqiu Coordinator of this site? Confirm its status | Shangqiu | China | Unknown status |
| Taizhou Enze Medical Center (Group), Enze Hospital Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Yueqing People's Hospital Coordinator of this site? Confirm its status | Yueqing | China | Unknown status |
| The Second People's Hospital of Yulin Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| Zhangpu County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Zibo Central hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.