Stroke Clinical Trial
— NICEOfficial title:
Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.
Status | Recruiting |
Enrollment | 656 |
Est. completion date | July 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 1. Subjects between 30 and 80 years. - 2. ICD-10 and CT/MRI criteria for acute cerebral infarction. - 3. Stroke within 7 days after onset. - 4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others) - 5. MoCA=26 at baseline. - 6.Hachinski ischemic score =7 at baseline. - 7.Expected good compliance to study. - 8.Informed consent signed. Exclusion Criteria: - 1.Diagnosis of schizophrenia, major anxiety syndrome, major depression. - 2.Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia. - 3.Dementia caused by (e.g., central nervous system trauma, tumor, infections, metabolic disorders, normal pressure hydrocephalus, lack of folic acid or vitamin B12, or thyroid hormone deficiency). - 4.Contraindications to dihydropyridine derivatives. - 5.Aphasia or other diseases that affect cognitive evaluation. - 6.Serious arrhythmias, bradycardia (<50 bpm) or tachycardia (>120 bpm); myocardial infarction within the past 6 months; blood pressure <90/60mmHg; severe renal or hepatic insufficiency; severe anemia, Hb<100g/L; severe gastrointestinal disorders; tumor. - 7.History of epilepsy, use of the antiepileptic drugs. - 8.CT/MRI showed neurodegenerative changes or other lesions except cerebral ischemia. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Beijing Tian Tan Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Ministry of Science and Technology of the People´s Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months | 6 months | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month | 1 month | No | |
Secondary | The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months | 3 months | No |
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