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

NCT ID: NCT06767969

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 892 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-04-01

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

There was no intervention and it was performed according to standardized clinical management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acetaminophen group

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.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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)

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xinyan Wang, MD

Role: CONTACT

alice1428656335@126.com

+8618513564393

Other Identifiers

wxy20241217ACEAIS

Identifier Type: -

Identifier Source: org_study_id