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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| The placebo group | Placebo Comparator | The placebo group patients will receive intra-arterial and intravenous sterile water for injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The methylprednisolone sodium succinate group | Drug | Intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracranial hemorrhage | Incidence of symptomatic intracranial hemorrhage | 48 hours |
| Mortality | Mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Shift in the distribution of mRS scores | Shift in the distribution of mRS scores | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Guo, MD | Contact | 0086-18729985168 | 18729985168@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Qu, MD | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| The placebo group | Drug | The placebo group patients will receive intra-arterial and intravenous sterile water for injection. |
|
| 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 | 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; | 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. | 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 | 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 | 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 | at 90 days |
| The incidence of malignant brain edema within 48 hours | The incidence of malignant brain edema within 48 hours | within 48 hours |
| EQ-5D scale score at 90 days | EQ-5D scale score at 90 days | at 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |