Ischemia StrokePhase 2IMPACT-LVONCT07516522
Intra-arterial Methylprednisolone After Endovascular Thrombectomy
A Phase 2 study testing The methylprednisolone sodium succinate group in people with Ischemia Stroke and Thrombectomy, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia Stroke, Thrombectomy, Large Vessel Occlusion
- What is being tested?
- The methylprednisolone sodium succinate group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Wei Guo, MD, 0086-18729985168, 18729985168@163.com
About this study
Official title: 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 = 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.
- Conditions
- Ischemia Stroke, Thrombectomy, Large Vessel Occlusion
- Being tested
- The methylprednisolone sodium succinate group, The placebo group
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The methylprednisolone sodium succinate groupDrug
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 groupDrug
The placebo group patients will receive intra-arterial and intravenous sterile water for injection.
| Study group | Role | What they receive |
|---|---|---|
| The methylprednisolone sodium succinate group | Experimental | 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. Receives: Drug: The methylprednisolone sodium succinate group |
| The placebo group | Placebo comparator | The placebo group patients will receive intra-arterial and intravenous sterile water for injection. Receives: Drug: The placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage
Measured: 48 hours
Mortality
Mortality
Measured: 90 days
Secondary outcomes (10)
Shift in the distribution of mRS scores
Shift in the distribution of mRS scores
Measured: 90 days
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment
Measured: within 48 hours after treatment
Proportion of patients with pneumonia within 7 days after EVT
Proportion of patients with pneumonia within 7 days after EVT
Measured: within 7 days after EVT
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;
Measured: within 7 days after EVT;
Incidence of serious adverse events within 7 days after EVT.
Incidence of serious adverse events within 7 days after EVT.
Measured: within 7 days after EVT.
The proportion of mRS score 0 to 4 at 90 days
The proportion of mRS score 0 to 4 at 90 days
Measured: at 90 days
The proportion of mRS score 0 to 3 at 90 days
The proportion of mRS score 0 to 3 at 90 days
Measured: at 90 days
The proportion of mRS score 0 to 2 at 90 days
The proportion of mRS score 0 to 2 at 90 days
Measured: at 90 days
The incidence of malignant brain edema within 48 hours
The incidence of malignant brain edema within 48 hours
Measured: within 48 hours
EQ-5D scale score at 90 days
EQ-5D scale score at 90 days
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start31 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia StrokeStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, MD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516522
- Sponsor's protocol ID
- K202602-29
- Acronym
- IMPACT-LVO
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT07516522
- Acronym / sponsor ID
- IMPACT-LVO / K202602-29
- Conditions
- Ischemia Stroke, Thrombectomy, Large Vessel Occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The methylprednisolone sodium succinate group | Experimental | Drug: The methylprednisolone sodium succinate groupThe 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 | Placebo comparator | Drug: The placebo groupThe placebo group patients will receive intra-arterial and intravenous sterile water for injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The methylprednisolone sodium succinate groupIntra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. | Drug | The methylprednisolone sodium succinate group |
| The placebo groupThe placebo group patients will receive intra-arterial and intravenous sterile water for injection. | Drug | The placebo group |
Primary outcome
Incidence of symptomatic intracranial hemorrhage
Time frame: 48 hours
Incidence of symptomatic intracranial hemorrhage
Mortality
Time frame: 90 days
Mortality
10 secondary outcomes
Shift in the distribution of mRS scores
Time frame: 90 days
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment
Time frame: within 48 hours after treatment
Proportion of patients with pneumonia within 7 days after EVT
Time frame: within 7 days after EVT
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;
Time frame: within 7 days after EVT;
Incidence of serious adverse events within 7 days after EVT.
Time frame: within 7 days after EVT.
The proportion of mRS score 0 to 4 at 90 days
Time frame: at 90 days
The proportion of mRS score 0 to 3 at 90 days
Time frame: at 90 days
The proportion of mRS score 0 to 2 at 90 days
Time frame: at 90 days
The incidence of malignant brain edema within 48 hours
Time frame: within 48 hours
EQ-5D scale score at 90 days
Time frame: at 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Qu, MD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The methylprednisolone sodium succinate group in people with Ischemia Stroke and Thrombectomy, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo, MD (0086-18729985168, 18729985168@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic intracranial hemorrhage (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.