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New treatment option for Acute Ischemic Stroke
Official title Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)
ClinicalTrials.gov ID: NCT07513233
What this study is testing
What is Anisodine Hydrobromide?
Anisodine Hydrobromide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18 to 80 years.
- Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1...
- 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.
You likely can't join if
- Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular...
- History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant...
- 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.
See the full eligibility 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...
- 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.
- 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 treatment clinical study within 30 days before enrollment, or current participation in another treatment clinical study.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, None Selected, China
- Huzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, None Selected, China; Huzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.