Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)

NCT ID: NCT01872858

Last Updated: 2013-06-07

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-11-30

Brief Summary

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Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin

Aspirin, 100mg, Q.D, p.o, 2yr

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin, 100mg, Q.D, p.o, 2yr

Cilostazol

cilostazol, 100mg, B.I.D, p.o, 2yr

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol, 100mg, B.I.D, p.o, 2yr

Interventions

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Aspirin

Aspirin, 100mg, Q.D, p.o, 2yr

Intervention Type DRUG

Cilostazol

cilostazol, 100mg, B.I.D, p.o, 2yr

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged between 50-80, both gender;
2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND;
3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.
4. Normal hepatic and renal function.
5. With good compliance.

Exclusion Criteria

1. Aged above 80 or less than 50.
2. Dementia.
3. Cerebral infarction(\>2cm).
4. Major vascular lesion. (stenosis\>50%).
5. Cardiac cerebral infarction.
6. Intracerebral Hemorrhage.
7. Clinical manifestations cannot attribute to small vessel disease.
8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.
9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).
10. Thrombocytopenic Purpura.
11. History of hemorrhage in digestive system or surgery in past 3 months.
12. Previously on cilostazol treatment for more than 3 month.
13. Allergic to aspirin or cilostazol.
14. Enrolled in other clinical trials in past 3 months.
15. Lack of informed consent or compliance.
16. Contraindications for MRI scan.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jianhui Fu

Department of Neurology, Huashan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jie Tang

Role: primary

+8618818210880

Other Identifiers

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jianhuifu2013

Identifier Type: -

Identifier Source: org_study_id

NCT01862575

Identifier Type: -

Identifier Source: nct_alias

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