Acute Ischemic StrokePhase 3IMPACT-LVONCT07141303
Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
A Phase 3 study testing The methylprednisolone sodium succinate in people with Acute Ischemic Stroke, 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
- Acute Ischemic Stroke
- What is being tested?
- The methylprednisolone sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,060 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2025to 30 Jun 2028
- Phase
- Phase 3
- 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; 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
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
Yan Qu, MD
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- The methylprednisolone sodium succinate, Placebo
- 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 succinateDrug
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.
PlaceboDrug
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 |
| The placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift in the distribution of mRS scores
Measured: 90 days
Incidence of symptomatic intracranial hemorrhage
Measured: 48 hours
Mortality
Measured: 90 days
Secondary outcomes (12)
The proportion of mRS score 0 to 4
Measured: 90 days
The proportion of mRS score 0 to 3
Measured: 90 days
The proportion of mRS score 0 to 2
Measured: 90 days
mRS scores
Measured: 1 year
The incidence of malignant brain edema
Measured: within 48 hours
Changes of NIHSS score
Measured: 5-7 days after surgery
EQ-5D scale score
Measured: 90 days
EQ-5D scale score
Measured: 1 year
Proportion of patients with any radiologic intracranial haemorrhage
Measured: within 48 hours after treatment
Proportion of patients with pneumonia
Measured: within 7 days after the treatment
Proportion of patients with gastrointestinal haemorrhage
Measured: within 7 days after treatment
Incidence of non-hemorrhagic serious adverse events
Measured: within 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start8 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Xianyang, First People's Hospital Of Tianshui, XD Group Hospital, Xi'an Aerospace General Hospital, First Affiliated Hospital of Chengdu Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141303
- Sponsor's protocol ID
- K202508-15
- Acronym
- IMPACT-LVO
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related papers published five years later, the IPD will be shared on ResMan.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. 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
- NCT07141303
- Acronym / sponsor ID
- IMPACT-LVO / K202508-15
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- First People's Hospital of Xianyang, First People's Hospital Of Tianshui, XD Group Hospital, Xi'an Aerospace General Hospital, First Affiliated Hospital of Chengdu Medical College
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2025 (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 = 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.
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 succinateThe 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: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 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 succinatePatients 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. | Drug | The methylprednisolone sodium succinate group |
| PlaceboThe placebo group patients will receive intra-arterial and intravenous sterile water for injection. | Drug | The placebo group |
Primary outcome
Shift in the distribution of mRS scores
Time frame: 90 days
Incidence of symptomatic intracranial hemorrhage
Time frame: 48 hours
Mortality
Time frame: 90 days
12 secondary outcomes
The proportion of mRS score 0 to 4
Time frame: 90 days
The proportion of mRS score 0 to 3
Time frame: 90 days
The proportion of mRS score 0 to 2
Time frame: 90 days
mRS scores
Time frame: 1 year
The incidence of malignant brain edema
Time frame: within 48 hours
Changes of NIHSS score
Time frame: 5-7 days after surgery
EQ-5D scale score
Time frame: 90 days
EQ-5D scale score
Time frame: 1 year
Proportion of patients with any radiologic intracranial haemorrhage
Time frame: within 48 hours after treatment
Proportion of patients with pneumonia
Time frame: within 7 days after the treatment
Proportion of patients with gastrointestinal haemorrhage
Time frame: within 7 days after treatment
Incidence of non-hemorrhagic serious adverse events
Time frame: within 7 days after treatment
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 18 Sep 2025.
- Individual participant dataSharing planned: Yes. Related papers published five years later, the IPD will be shared on ResMan.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The methylprednisolone sodium succinate in people with Acute Ischemic Stroke, 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 1 inclusion and 15 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 18 Sep 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Shift in the distribution of mRS scores (time frame: 90 days). The study lists 3 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 18 Sep 2025.