NCT07141303RecruitingPhase 3
Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
Source: ClinicalTrials.gov · Last updated 18 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1060 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- Aug 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Stroke
- NCT number
- NCT07141303
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1060
- From Aug 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
- History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
- Terminal illness with life expectancy \<6 months;
- Active systemic infectious disease
- Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
Lab values
- Allergy to iodinated contrast media, or methylprednisolone sodium succinate
- Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) \>1.7
- Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m\^2 or serum creatinine \> 220μmol/L (2.5mg/dl));
- Blood glucose \< 2.8mmol/L (50mg/dl) or \> 22.2mmol/L (400mg/dl);
Other
- Prestroke mRS score \>= 2
- pregnant or lactating patients
- Participating in other clinical research;
- Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
- Anticipated inability to complete follow-up
- Puncture to recanalization was more than 90 minutes; Total thrombectomy passes \>3
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.