Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2)

NCT07800572 | Recruiting Phase 2 DMC

• 1 other identifier: HEAL-2
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular Treatment; Neuroprotection; Stroke

Outcome Measures

Primary Outcomes (1)

• Cerebral Infarct Volume on Day 8

  Day 8

Secondary Outcomes (8)

• NIHSS Score at 24 Hours

  24 hours

• NIHSS Score on Day 8

  Day 8

• Change in NIHSS Score From Baseline to Day 8

  Baseline to Day 8

• mRS Score of 0-1 at 90 Days

  90 Days

• mRS Score of 0-2 at 90 Days

  90 Days

Other Outcomes (4)

• Neurological Deterioration Within 24 Hours

  Within 24 hours

• Symptomatic Intracranial Hemorrhage Within 8 Days

  Within 8 Days

• All Cause Mortality at 90 Days

  Within 90 days

Study Arms (2)

Anisodine Hydrobromide Group

EXPERIMENTAL

Participants will receive anisodine hydrobromide combined with endovascular thrombectomy.

Drug: Anisodine Hydrobromide

Anisodine Hydrobromide placebo

PLACEBO COMPARATOR

Participants will receive placebo combined with endovascular thrombectomy.

Drug: Anisodine Hydrobromide Placebo

Interventions

Anisodine Hydrobromide Placebo DRUG

An equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses.

Anisodine Hydrobromide placebo

Anisodine Hydrobromide DRUG

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.

Anisodine Hydrobromide Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (11)

Anyang People's Hospital

Anyang, China

NOT YET RECRUITING

Xuanwu Hospital，Capital Medical University

Beijing, China

RECRUITING

Anji County People's Hospital

Huzhou, China

RECRUITING

Jiuquan People's Hospital

Jiuquan, China

RECRUITING

Lishui Central Hospital

Lishui, China

NOT YET RECRUITING

Shangqiu First People's Hospitl

Shangqiu, China

RECRUITING

Suzhou Municipal Hospital of Anhui Province

Suzhou, China

RECRUITING

Taizhou Enze Medical Center (Group) Enze Hospital

Taizhou, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

RECRUITING

Zhangpu County Hospital

Zhangzhou, China

RECRUITING

Zibo Central Hospital

Zibo, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

anisodine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xunming Ji, PhD/MD

CONTACT

01083198962; jixm@ccmu.edu.cn

Chuanjie Wu, PhD/MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 2, 2026
• Study Start: September 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)