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

NCT ID: NCT01220622

Last Updated: 2010-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nimodipine

Group Type ACTIVE_COMPARATOR

Nimodipine

Intervention Type DRUG

Administration of nimodipine 30mg tid for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of placebo 30mg tid for 6 months

Interventions

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Nimodipine

Administration of nimodipine 30mg tid for 6 months

Intervention Type DRUG

Placebo

Administration of placebo 30mg tid for 6 months

Intervention Type DRUG

Other Intervention Names

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Nimodiping Pian Control group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Beijing Tian Tan Hospital, Capital Medical University, China

Principal Investigators

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Wang Yongjun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Locations

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Beijing Tian Tan Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng tao, M.D.

Role: CONTACT

[email protected]
00861067098343

Wang xuemei, M.D.

Role: CONTACT

[email protected]

Facility Contacts

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Feng tao, M.D.

Role: primary

[email protected]
00861067098343

Wang xuemei, M.D.

Role: backup

[email protected]

References

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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.

Reference Type DERIVED
PMID: 36659633 (View on PubMed)

Other Identifiers

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BSP-SOP-040

Identifier Type: -

Identifier Source: org_study_id