Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07800572

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anyang People's Hospital, Anyang, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Placebo

Drug

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

Primary outcomes

  1. Cerebral Infarct Volume on Day 8

    Time frame: Day 8

Secondary outcomes

  1. NIHSS Score at 24 Hours

    Time frame: 24 hours

  2. NIHSS Score on Day 8

    Time frame: Day 8

  3. Change in NIHSS Score From Baseline to Day 8

    Time frame: Baseline to Day 8

  4. mRS Score of 0-1 at 90 Days

    Time frame: 90 Days

  5. mRS Score of 0-2 at 90 Days

    Time frame: 90 Days

  6. Distribution of mRS scores at 90 Days

    Time frame: 90 Days

  7. EQ-5D-5L at 90 Days

    Time frame: 90 Days

  8. Barthel Index Score of 95-100 at 90 Days

    Time frame: 90 Days

Other outcomes

  1. Neurological Deterioration Within 24 Hours

    Time frame: Within 24 hours

    an increase of ≥4 points in the NIHSS score from baseline

  2. Symptomatic Intracranial Hemorrhage Within 8 Days

    Time frame: Within 8 Days

  3. All Cause Mortality at 90 Days

    Time frame: Within 90 days

  4. Intracranial Hemorrhage Within 8 Days

    Time frame: Within 8 Days

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanjie Wu, PhD/MD

CONTACT

Xunming Ji, PhD/MD

CONTACT

[email protected]

01083198962

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.