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New treatment option for Acute Ischemic Stroke
Official title Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
ClinicalTrials.gov ID: NCT07141303
What this study is testing
What is The methylprednisolone sodium succinate?
The methylprednisolone sodium succinate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1. 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...
You likely can't join 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
See the full eligibility criteria
- 1. 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...
- 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 \ 220μmol/L (2.5mg/dl));
- Terminal illness with life expectancy \<6 months;
- Blood glucose \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.