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The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.
656 patients diagnosed with acute cerebral ischemia disease (onset≤7d) based on ICD-10 and CT/MRI criteria, who have cognitive impairment meeting all of the inclusion criteria and none of the exclusion criteria, will be included and randomized into nimodipine treatment group and the controlled group.Evaluations of cognitive function will be taken at baseline, 1 month, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimodipine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimodipine | Drug | Administration of nimodipine 30mg tid for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population | 6 months | |
| The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng tao, M.D. | Contact | 00861067098343 | happyft@sina.com | |
| Wang xuemei, M.D. | Contact | minnie_wxm@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Yongjun, M.D. | Beijing Tian Tan Hospital, Capital Medical University, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tian Tan Hospital, Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36659633 | Derived | Zheng H, Wang Y, Wang A, Li H, Wang D, Zhao X, Wang P, Shen H, Zuo L, Pan Y, Li Z, Meng X, Wang X, Shi W, Ju Y, Liu L, Dong K, Wang C, Sui R, Xue R, Pan X, Niu X, Luo B, Sui Y, Wang H, Feng T, Wang Y; NICE trial group. The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized, placebo-controlled trial. Sci Bull (Beijing). 2019 Jan 30;64(2):101-107. doi: 10.1016/j.scib.2018.12.006. Epub 2018 Dec 8. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009553 | Nimodipine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Administration of placebo 30mg tid for 6 months |
|
|
| Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 3 months in the ITT population | 3 months |
| Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population | 3 months |
| The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month | 1 month |
| The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months | 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009539 |
| Nicotinic Acids |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |