Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes (NICE)

Ministry of Science and Technology of the People´s Republic of China

Status and phase: Unknown; Phase 4

Conditions: Stroke; Mild Cognitive Impairment

Treatments: Drug: Placebo; Drug: Nimodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01220622

BSP-SOP-040

Details and patient eligibility

About

The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.

Full description

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.

Enrollment: 656 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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656 participants in 2 patient groups, including a placebo group

Nimodipine

Active Comparator group

Treatment:

Drug: Nimodipine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo