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NCT Number: NCT07516522

Intra-arterial Methylprednisolone After Endovascular Thrombectomy

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.

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Key information

Conditions

Ischemia Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Large Vessel Occlusion Nervous System Diseases Stroke Thrombectomy Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Total thrombectomy passes >3

Treatment and study plan

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 placebo group

Drug

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

Primary outcomes

  1. Incidence of symptomatic intracranial hemorrhage

    Time frame: 48 hours

    Incidence of symptomatic intracranial hemorrhage

  2. Mortality

    Time frame: 90 days

    Mortality

Secondary outcomes

  1. Shift in the distribution of mRS scores

    Time frame: 90 days

    Shift in the distribution of mRS scores

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

    Time frame: within 48 hours after treatment

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

  3. Proportion of patients with pneumonia within 7 days after EVT

    Time frame: within 7 days after EVT

    Proportion of patients with pneumonia within 7 days after EVT

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

    Time frame: within 7 days after EVT;

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

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

    Time frame: within 7 days after EVT.

    Incidence of serious adverse events within 7 days after EVT.

  6. The proportion of mRS score 0 to 4 at 90 days

    Time frame: at 90 days

    The proportion of mRS score 0 to 4 at 90 days

  7. The proportion of mRS score 0 to 3 at 90 days

    Time frame: at 90 days

    The proportion of mRS score 0 to 3 at 90 days

  8. The proportion of mRS score 0 to 2 at 90 days

    Time frame: at 90 days

    The proportion of mRS score 0 to 2 at 90 days

  9. The incidence of malignant brain edema within 48 hours

    Time frame: within 48 hours

    The incidence of malignant brain edema within 48 hours

  10. EQ-5D scale score at 90 days

    Time frame: at 90 days

    EQ-5D scale score at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Guo, MD

CONTACT

[email protected]

0086-18729985168

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion

Acronym: IMPACT-LVO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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