NCT07513233 Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)
| NCT ID | NCT07513233 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Capital Medical University |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 92 participants in total. It began in 2026-04-28 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07513233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07513233 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07513233 currently recruiting?
Yes, NCT07513233 is actively recruiting participants. Contact the research team at jixm@ccmu.edu.cn for enrollment information.
Where is the NCT07513233 trial being conducted?
This trial is being conducted at Beijing, China, Huzhou, China.
Who is sponsoring the NCT07513233 clinical trial?
NCT07513233 is sponsored by Capital Medical University. The trial plans to enroll 92 participants.
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