NCT07516522 Intra-arterial Methylprednisolone After Endovascular Thrombectomy
| NCT ID | NCT07516522 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tang-Du Hospital |
| Condition | Ischemia Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2026-03-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Yan Qu, MD
PRINCIPAL INVESTIGATOR
Tang-Du Hospital
Frequently Asked Questions
Who can join the NCT07516522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemia Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07516522 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07516522 currently recruiting?
Yes, NCT07516522 is actively recruiting participants. Contact the research team at 18729985168@163.com for enrollment information.
Where is the NCT07516522 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07516522 clinical trial?
NCT07516522 is sponsored by Tang-Du Hospital. The principal investigator is Yan Qu, MD at Tang-Du Hospital. The trial plans to enroll 210 participants.
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