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A multi-center real-world study for the efficacy and safety of anisodine hydrobromide injection in treatment of acute ischemic stroke

A multi-center real-world study for the efficacy and safety of anisodine hydrobromide injection in treatment of acute ischemic stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027517
Enrollment
Unknown
Registered
2019-11-17
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Group 1:1.Basic treatment: According to the patient's clinical history, symptoms and other specific conditions, the patient-in-charge physician refers to "China's Guidelines for the Diagnosis and Trea
Group 2:Patients who did not use anisoprofen hydrobromide injection

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with ischemic stroke admitted to hospital (meet with the "China Acute Ischemic Stroke Diagnosis and Treatment Guide 2014" ischemic stroke diagnostic criteria), CT/MRI examination to exclude cerebral hemorrhage; (2) Aged >= 18 years, gender is not limited; (3) The time from onset to admission is <= 30 days; (4) The patient or family member informed the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Neuroimaging (CT/MRI) confirmed acute intracranial hemorrhage, tumor, encephalitis or other non-vascular intracranial lesions; (2) Pregnant and lactating women; (3) Poor compliance, unable to complete or refuse to complete the follow-up; (4) Those with severe organ dysfunction; (5) The condition is critical and the life expectancy is less than three months.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with 90-day adverse prognosis (i.e. death or disability, modified Rankin scale, mRS = 3-6 points);

Secondary

MeasureTime frame
Changes of NIHSS score at discharge compared with baseline and comparison between the two groups;Incidence of hemorrhagic transformation after cerebral infarction during hospitalization;90-day mortality rate;90-day mRS grade migration;90-day recurrence of stroke;Improvement of cerebral collateral circulation/perfusion during CTA and/or CTP examinations 7-14 days after the start of medication;The change of brain edema in patients with CT/MRI examination 7-14 days after the beginning of medication;Cardiovascular adverse events (heart rate, blood pressure) during medication;Adverse events during medication: facial flushing, gastrointestinal reaction, blurred vision, pulmonary infection, dysuria, urinary retention, headache;Vital signs (temperature, pulse, breathing, blood pressure) during medication;ECG examination during medication;Laboratory examination during medication (blood routine, blood sugar, blood lipid, liver and kidney function, myocardial enzymes, blood electrolyte, coagulation function);

Countries

China

Contacts

Public ContactWu Bo

West China Hospital of Sichuan University

dragonwb@126.com+86 18980602142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 23, 2026