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NCT Number: NCT07141303

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

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 = 1010 patients (n=505 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 5% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=1060 patients (n=530 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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location status: Recruiting

Location contact

Wei Guo, MD

CONTACT

[email protected]

0086-18729985168

Yan Qu, MD

PRINCIPAL_INVESTIGATOR

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; 2) The time from onset to randomization was within 24 hours; 3) 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; 4) NIHSS score >= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT >=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) 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

Drug

Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

Placebo

Drug

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

Primary outcomes

  1. Shift in the distribution of mRS scores

    Time frame: 90 days

  2. Incidence of symptomatic intracranial hemorrhage

    Time frame: 48 hours

  3. Mortality

    Time frame: 90 days

Secondary outcomes

  1. The proportion of mRS score 0 to 4

    Time frame: 90 days

  2. The proportion of mRS score 0 to 3

    Time frame: 90 days

  3. The proportion of mRS score 0 to 2

    Time frame: 90 days

  4. mRS scores

    Time frame: 1 year

  5. The incidence of malignant brain edema

    Time frame: within 48 hours

  6. Changes of NIHSS score

    Time frame: 5-7 days after surgery

  7. EQ-5D scale score

    Time frame: 90 days

  8. EQ-5D scale score

    Time frame: 1 year

  9. Proportion of patients with any radiologic intracranial haemorrhage

    Time frame: within 48 hours after treatment

  10. Proportion of patients with pneumonia

    Time frame: within 7 days after the treatment

  11. Proportion of patients with gastrointestinal haemorrhage

    Time frame: within 7 days after treatment

  12. Incidence of non-hemorrhagic serious adverse events

    Time frame: within 7 days after treatment

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

Collaborators

  • First Affiliated Hospital of Chengdu Medical College
  • First People's Hospital Of Tianshui
  • First People's Hospital of Xianyang
  • XD Group Hospital
  • Xi'an Aerospace General Hospital

Registry information

Acronym: IMPACT-LVO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2025
Registry last updated
Sep 18, 2025

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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