Acute Ischemic Stroke
Conditions
Keywords
Endovascular Treatment, Neuroprotection, Stroke
Brief summary
This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.
Detailed description
Eligible participants will be randomly assigned to receive anisodine hydrobromide or matching placebo in addition to standard care, with efficacy and safety assessed during follow-up.
Interventions
Anisodine hydrobromide, 2 mg per dose, diluted in 0.9% sodium chloride solution and administered by intravenous infusion twice daily for a total of 14 doses.
An equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Anterior-circulation large-vessel occlusion involving the intracranial ICA, M1, or proximal/dominant M2 * Eligible for endovascular treatment within 24 hours of last known well * Baseline NIHSS score ≥6 * Baseline ASPECTS ≥6 * Pre-stroke mRS score 0-1 * Written informed consent provided by the participant or legally authorized representative
Exclusion criteria
* Intracranial hemorrhage on baseline imaging * Significant bleeding disorder or coagulopathy * Vascular anatomy unsuitable for EVT * Pregnancy, breastfeeding, or planned pregnancy within 90 days * Known hypersensitivity or severe intolerance to anisodine hydrobromide * Contraindication to anticholinergic drugs * Severe arrhythmia or hemodynamic instability * Severe psychiatric disorder, dementia, or impaired consciousness precluding consent or follow-up * Malignancy or other severe systemic disease with a life expectancy \<90 days * Participation in another clinical trial within 30 days before enrollment or concurrently * Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral Infarct Volume on Day 8 | Day 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS Score at 24 Hours | 24 hours | — |
| NIHSS Score on Day 8 | Day 8 | The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment and a worse outcome. |
| Change in NIHSS Score From Baseline to Day 8 | Baseline to Day 8 | The NIHSS ranges from 0 to 42. Change is calculated as the Day 8 score minus the baseline score. |
| mRS Score of 0-1 at 90 Days | 90 Days | The mRS ranges from 0 to 6, with higher scores indicating greater disability or death. |
| mRS Score of 0-2 at 90 Days | 90 Days | The mRS ranges from 0 to 6, with higher scores indicating greater disability or death |
| Distribution of mRS scores at 90 Days | 90 Days | The mRS ranges from 0 to 6, with higher scores indicating greater disability or death. |
| EQ-5D-5L at 90 Days | 90 Days | The EQ-5D-5L index score ranges from -0.391 to 1.000 using the Chinese value set, with higher scores indicating better health-related quality of life. |
| Barthel Index Score of 95-100 at 90 Days | 90 Days | The Barthel Index ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living. |
Countries
China
Contacts
CONTACTXunming Ji, PhD/MD
CONTACTChuanjie Wu, PhD/MD
Outcome results
None listed