Effect of Acetaminophen on Neurological Outcome in Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke
• Interventions: Drug: Acetaminophen

• Registration Number: NCT06767969
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Neuro-inflammation response plays an important role in the development of acute ischemic stroke(AIS). The aim of this study was to conduct a prospective randomized controlled study on the effect of acetaminophen on long-term neurological prognosis in AIS patients undergoing endovascular treatment(EVT). The primary outcome was the incidence of neurological independence (mRS 0-2, modified Rankin scale) at 90 days after surgery. The secondary outcome measures were early neurological outcome (NIHSS score at 7 days after surgery or at discharge) and the incidence of symptomatic intracerebral hemorrhage during hospitalization. This study explored the effect of acetaminophen on the prognosis of neurological function of patients, and the expected results provide evidence of safety and effectiveness for acetaminophen to improve the prognosis of neurological function of patients, and provide theoretical and practical basis for the subsequent "new use of old drugs" of acetaminophen and large sample and multi-center clinical research or clinical application.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Status Verified: 2025-02
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-01-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 892

Inclusion Criteria

• Age ≥18 years old; computer tomography angiogram (CTA), Magnetic Resonance Angiography (MRA), MRA) or digital subtraction angiography (DSA) confirmed the presence of large intracranial artery occlusion (intracranial internal carotid artery, anterior cerebral artery, M1 and M2 segments of middle cerebral artery, basilar artery, posterior cerebral artery); Endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, etc. was performed (within 24 hours of onset). The NIHSS score at admission was 6-26. The mRS Score before onset was less than 2. Patients or their legal representatives provided written informed consent

Exclusion Criteria

The mRS Score before the stroke was ≥2. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc. Patients had a history of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia. Renal insufficiency with elevated serum creatinine (> 2 times the upper limit of normal); Severe hepatic insufficiency or liver disease, with elevations in liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or gamma-glutamyl transpeptidase) of more than twice the upper limit of the normal range; Patients with severe active liver disease; Patients with severe heart and lung diseases considered by the investigator to be ineligible for the study; DSA examination is contraindicated, severe contrast agent allergy or iodine contrast agent is absolutely contraindicated; Women of childbearing age, pregnant or lactating women who have a negative pregnancy test but refuse to use effective contraception; Inability to complete the study due to mental disorders, cognitive or emotional disorders; Allergy to acetaminophen; Other patients who were not included in the study in the opinion of the investigator (reasons indicated)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen group	Acetaminophen	Acetaminophenl 500mg (500mg/50ml) was infused intravenously every 6 hours( a single infusion is completed within 15-30 minutes) from the beginning of endovascular treatment to 48 hours after treatment.

Primary Outcome Measures

Name	Time	Method
The incidence of functional independence	90 (±7) days after treatment	modified Rankin score from 0 to 2