Intra-arterial Methylprednisolone After Endovascular Thrombectomy

NCT07516522 | Recruiting Phase 2 DMC

• 1 other identifier: K202602-29
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successful endovascular thrombectomy in anterior circulation large vessel occlusion patients. This is a multicenter, randomized, double-blind, placebo-controlled trial. Acute ischemia stroke patients with anterior circulation large vessel occlusion within 24 hours from last known well will be screened for this trial. Successful recanalization after mechanical thrombectomy (eTICI 2b-3) patients will be randomized 1:1 to either methylprednisolone sodium succinate group or placebo group. The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. The placebo group patients will receive intra-arterial and intravenous sterile water for injection. The shift on modified Rankin Scale score is designed to detect in the present trial. A sample size of n = 178 patients (n=89 per group) is required. The intention-to-treat principle will be applied to the primary analysis, therefore, to safeguard against dilution of the treatment effect associated with an approximate 15% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=210 patients (n=105 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.

Conditions

Ischemia Stroke; Thrombectomy; Large Vessel Occlusion

Outcome Measures

Primary Outcomes (2)

• Incidence of symptomatic intracranial hemorrhage

  Incidence of symptomatic intracranial hemorrhage

  48 hours

• Mortality

  Mortality

  90 days

Secondary Outcomes (10)

• Shift in the distribution of mRS scores

  90 days

• Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment

  within 48 hours after treatment

• Proportion of patients with pneumonia within 7 days after EVT

  within 7 days after EVT

• Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;

  within 7 days after EVT;

• Incidence of serious adverse events within 7 days after EVT.

  within 7 days after EVT.

Study Arms (2)

The methylprednisolone sodium succinate group

EXPERIMENTAL

The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

Drug: The methylprednisolone sodium succinate group

The placebo group

PLACEBO COMPARATOR

The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

Drug: The placebo group

Interventions

The methylprednisolone sodium succinate group DRUG

Intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

The methylprednisolone sodium succinate group

The placebo group DRUG

The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

The placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old;
• The time from onset to randomization was within 24 hours;
• Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke;
• NIHSS score \>= 6 points
• Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT \>=3;
• Successful endovascular thrombectomy (eTICI 2b50-3)
• Written informed consent signed by patients or their family members

You may not qualify if:

• Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Prestroke mRS score \>= 2
• pregnant or lactating patients
• Allergy to iodinated contrast media, or methylprednisolone sodium succinate
• Participating in other clinical research;
• Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) \>1.7
• History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m\^2 or serum creatinine \> 220μmol/L (2.5mg/dl));
• Terminal illness with life expectancy \<6 months;
• Blood glucose \< 2.8mmol/L (50mg/dl) or \> 22.2mmol/L (400mg/dl);
• Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
• Active systemic infectious disease
• Anticipated inability to complete follow-up
• Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
• Puncture to recanalization was more than 90 minutes;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Qu, MD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Guo, MD

CONTACT

0086-18729985168; 18729985168@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 8, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)