Ischemic Stroke, AcutePEARL-MERITNCT07175649
Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke
A study testing Methylprednisolone sodium succinate in people with Ischemic Stroke, Acute, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Methylprednisolone sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 912 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Dec 2029
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 85 years;
- Clinically diagnosed acute ischemic stroke with screening NIHSS ≥6;
- Time from last known well to randomization ≤24 hours;
- Pre-stroke mRS score of 0-1;
- Occlusion of the responsible vessel confirmed by CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) in intracranial segment of internal carotid artery (ICA), M1 or M2 segment of middle cerebral artery (MCA), and plan to undergo EVT;
- Alberta Stroke Program Early CT Score (ASPECTS) of 0-5 on NCCT, or ischemic core volume ≥70 mL (defined as regional cerebral blood flow [rCBF] <30% on CT perfusion [CTP] or apparent diffusion coefficient [ADC] <620×10-⁶ mm²/s on MRI);
- Informed consent obtained.
Who cannot join
- Intracranial hemorrhage on NCCT or MRI;
- Allergy to corticosteroids;
- Allergy to contrast agents;
- Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment;
- Random blood glucose >22.2 mmol/L (400 mg/dL);
- Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) >1.7, or administration of novel oral anticoagulants within 48 hours of symptom onset;
Show all 16Show fewer
- Platelet count <90×10⁹/L;
- History of gastrointestinal or urinary tract bleeding within the last month;
- Current participation in another interventional clinical trial;
- Pregnancy or lactating;
- Renal dysfunction with an estimated glomerular filtration rate (eGFR) <30 mL/min or serum creatinine >220 μmol/L (2.5 mg/dL);
- Persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive treatment;
- Life expectancy <6 months due to terminal illnesses such as malignancy or severe cardiopulmonary disease;
- Intracranial aneurysm or arteriovenous malformation;
- Intracranial tumour with mass effect on imaging (except for small meningiomas);
- Other conditions deemed unsuitable for study participation by the investigator, including inability to comprehend and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders.
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
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Xinguang Yang, MD, yangxinguang0926@163.com
Yamei Tang, PhD
About this study
Official title: Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke: A Randomized, Double-blind, Placebo-controlled Trial
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.
Read the detailed description
The PEARL-MERIT is a multicenter, prospective, randomized, double-blind, placebo-controlled trial. A total of 912 patients (aged 18-85 years) within 24 hours of symptom onset of acute ischemic stroke, who have imaging evidence of an occlusion of the intracranial internal carotid artery (ICA) and/or M1/M2 segment of middle cerebral artery (MCA), a large infarct core, and a planned EVT, will be enrolled.
Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into 2 groups after obtaining informed consent. One group will receive methylprednisolone, the other group will receive placebo. The primary objective is to evaluate the efficacy of methylprednisolone with EVT compared to placebo with EVT in patients with acute ischemic stroke due to anterior circulation LVO and a large infarct core.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- 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.
Methylprednisolone sodium succinateDrug
Also called Methylprednisolone
Intravenous methylprednisolone sodium succinate will be administered at a dose of 2 mg/kg/day for 3 days, with a maximum daily dose of 160 mg (4 vials, 40 mg/vial).
It is recommended that the initial dose be administered as soon as possible after randomization.
PlaceboDrug
Matched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone group | Experimental | Not described Receives: Drug: Methylprednisolone sodium succinate |
| 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.
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90 (±14) days
Measured: 90±14 days after randomization
Secondary outcomes (8)
The distribution of the modified Rankin Scale scores
The shift analysis of mRS at 90±14 days (merged 0-1)
Measured: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-4
The proportion of mRS score 0-4 at 90 (±14) days
Measured: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90 (±14) days
Measured: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days
Measured: 90±14 days after randomization
Quality of Life (EQ-5D-5L)
Quality of life measured by EQ-5D-5L scale score at 90 (±14) days
Measured: 90±14 days after randomization
Neurologic deficit (NIHSS score) changes
National Institutes of Health Stroke Scale (NIHSS) score change from baseline, at 7 (±1) days or at discharge
Measured: 7±1 days after randomization/at discharge
Infarct core volume changes
Infarct core volume change from baseline, assessed with NCCT at 7±1 days after randomization/at discharge or with MRI at 36±12 hours
Measured: 7±1 days after randomization/at discharge or at 36±12 hours after randomization
Rate of decompressive craniectomy
Rate of decompressive craniectomy at 7 (±1) days
Measured: 7±1 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175649
- Sponsor's protocol ID
- SYSKY-2025-603-03
- Acronym
- PEARL-MERIT
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07175649
- Acronym / sponsor ID
- PEARL-MERIT / SYSKY-2025-603-03
- Conditions
- Ischemic Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Sep 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.
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.
Detailed description
The PEARL-MERIT is a multicenter, prospective, randomized, double-blind, placebo-controlled trial. A total of 912 patients (aged 18-85 years) within 24 hours of symptom onset of acute ischemic stroke, who have imaging evidence of an occlusion of the intracranial internal carotid artery (ICA) and/or M1/M2 segment of middle cerebral artery (MCA), a large infarct core, and a planned EVT, will be enrolled.
Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into 2 groups after obtaining informed consent. One group will receive methylprednisolone, the other group will receive placebo. The primary objective is to evaluate the efficacy of methylprednisolone with EVT compared to placebo with EVT in patients with acute ischemic stroke due to anterior circulation LVO and a large infarct core.
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 |
|---|---|---|
| Methylprednisolone group | Experimental | Drug: Methylprednisolone sodium succinate |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 85 years;
- Clinically diagnosed acute ischemic stroke with screening NIHSS ≥6;
- Time from last known well to randomization ≤24 hours;
- Pre-stroke mRS score of 0-1;
- Occlusion of the responsible vessel confirmed by CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) in intracranial segment of internal carotid artery (ICA), M1 or M2 segment of middle cerebral artery (MCA), and plan to undergo EVT;
Key exclusion criteria (16 listed)
- Intracranial hemorrhage on NCCT or MRI;
- Allergy to corticosteroids;
- Allergy to contrast agents;
- Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment;
- Random blood glucose >22.2 mmol/L (400 mg/dL);
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 |
|---|---|---|
| Methylprednisolone sodium succinateAlso: MethylprednisoloneIntravenous methylprednisolone sodium succinate will be administered at a dose of 2 mg/kg/day for 3 days, with a maximum daily dose of 160 mg (4 vials, 40 mg/vial). It is recommended that the initial dose be administered as soon as possible after randomization. | Drug | Methylprednisolone group |
| PlaceboMatched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials. | Drug | Placebo group |
Primary outcome
The modified Rankin Scale score (mRS) 0-3
Time frame: 90±14 days after randomization
The proportion of mRS score 0-3 at 90 (±14) days
8 secondary outcomes
The distribution of the modified Rankin Scale scores
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-4
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-2
Time frame: 90±14 days after randomization
The modified Rankin Scale score (mRS) 0-1
Time frame: 90±14 days after randomization
Quality of Life (EQ-5D-5L)
Time frame: 90±14 days after randomization
Neurologic deficit (NIHSS score) changes
Time frame: 7±1 days after randomization/at discharge
Infarct core volume changes
Time frame: 7±1 days after randomization/at discharge or at 36±12 hours after randomization
Rate of decompressive craniectomy
Time frame: 7±1 days after randomization
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 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone sodium succinate in people with Ischemic Stroke, Acute, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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: opening soon, as of the sponsor's last update on 16 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.
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 Xinguang Yang (86 + 13076822010, yangxinguang0926@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score (mRS) 0-3 (time frame: 90±14 days after randomization). 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 16 Sep 2025.