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This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.
The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposet group | intravenous edaravone dexborneol 37.5mg twice daily |
| |
| Non-exposed group | standard treatment at the discretion of local clinicians |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| edaravone dexborneol | Drug | intravenous edaravone dexborneol 37.5mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Scale (mRS) score 0-1 | Proportion of patients with modified Rankin Scale (mRS) score (on a scale from 0 to 6, with higher scores indicating greater disability) of 0 to 1 at 90±7 days | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS 0-2 | Proportion of patients with mRS score of 0 to 2 at 90±7 days | 90±7 days |
| Distribution of mRS score | Distribution of mRS score at 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage (sICH) | Symptomatic intracranial hemorrhage during hospitalization | during hospitalization, an average of 7 days |
| Intracranial hemorrhage during hospitalization (ICH) |
Inclusion Criteria:
Exclusion Criteria:
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Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Junwei Hao | Recruiting | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41467380 | Derived | Ma G, Raynald, Arham A, Jiang Z, Mo R, Zuo Y, Wu Y, Meng S, Lei S, Nguyen TN, Zhong L; EXPAND investigators. Edaravone Dexborneol in Large Ischemic Stroke: Real-World Experience from a Multicenter Study in China. J Am Heart Assoc. 2026 Jan 6;15(1):e044296. doi: 10.1161/JAHA.125.044296. Epub 2025 Dec 30. | |
| 40763317 | Derived |
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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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| 90±7 days |
| Neurological functional change | The change of NIHSS score at discharge compared with the baseline NIHSS score | at discharge, an average of 7 days |
| Quality of Life (EQ-5D-5L) at 90 days | The value of EQ-5D-5L at 90±7 days | 90±7 days |
Intracranial hemorrhage during hospitalization, an average of 7 days
| during hospitalization |
| All-cause death | All-cause mortality at 90±7 days | 90±7 days |
| Adverse events | Adverse events during the use of edaravone dexborneol | during the use of edaravone dexborneol |
| Ma G, Mo R, Yao X, Nguyen TN, Song Z, Xie W, Yuan G, Zuo Y, Wu Y, Lei S, Meng S, Wu Y, Jiang Z, Liu H, Ren Y, Wang P, Gao D, Chang H, Guo Y, Zhang Q, Ma Q, Zhong L, Song H, Hao J. Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke: A Multicenter, Prospective, Cohort Study. Neurology. 2025 Aug 26;105(4):e213949. doi: 10.1212/WNL.0000000000213949. Epub 2025 Aug 5. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |