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ACTIVE NOT RECRUITING
NCT07513233
PHASE1

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

Sponsor: Capital Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2026-04-28

Completion Date

2026-11-20

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

DRUG

Anisodine Hydrobromide

Anisodine hydrobromide injection is administered intravenously in addition to standard endovascular therapy for acute ischemic stroke. The investigational drug is diluted in 250 mL of 0.9% sodium chloride solution and infused over approximately 60 minutes. Treatment is given twice daily (BID) for 7 consecutive days, with the first dose initiated prior to vascular recanalization. In this Phase Ib study, four dose levels (1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg per dose) are evaluated using a sequential, cohort-based dose-escalation design to assess safety, tolerability, and dose feasibility. All participants receive standard-of-care endovascular therapy according to current clinical guidelines, including mechanical thrombectomy and/or adjunctive procedures as clinically indicated.

Locations (10)

Zhangpu County Hospital

Zhangzhou, Fujian, China

Jiuquan City People's Hospital

Jiuquan, Gansu, China

The Second People's Hospital of Yulin

Yulin, Guangxi, China

The First People's Hospital of Shangqiu

Shangqiu, Henan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Xuanwu Hospital, Capital Medical University

Beijing, None Selected, China

Zibo Central Hospital

Zibo, Shandong, China

Anji County People's Hospital

Huzhou, Zhejiang, China

Taizhou Enze Medical Center (Group) Enze Hospital

Taizhou, Zhejiang, China

Yueqing People's Hospital

Yueqing, Zhejiang, China