Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions

NCT ID: NCT00847860

Last Updated: 2015-05-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Dementia Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Cilostazol

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Cilostazol 100 mg bid for 12 months

2

Asprin

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 100 mg qd for 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilostazol

Cilostazol 100 mg bid for 12 months

Intervention Type DRUG

Aspirin

Aspirin 100 mg qd for 12 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ranging from 40 to 80 years
2. After newly ischemic stroke from 3 months to 2 years
3. Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)\>=4
4. Moderate or mild cognitive deficits: MMSE 12-26
5. Vascular or mixed dementia: Hachinski ischemic score\>4
6. Moderate or mild disability: MRS\<=4,NIHSS\<20
7. Informed consent

Exclusion Criteria

1. Definitive diagnosis of dementia prior to the stroke
2. Cerebral hemorrhage in the past
3. Cerebral embolism result from cardiogenic embolus
4. Critically ills: MRS\>4,NIHSS\>=20
5. Bed-ridden patient who is hardly discovered newly stroke
6. patient with sever cardiac, hepatic or nephric complication
7. dementia caused not by vascular lesions
8. other diseases disturb the cognitive evaluation
9. susceptibility to varieties of allergen
10. abstain from Cilostazol or Asprin
11. antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
12. rejected to participate by the patient or the family
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhejiang Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peking University First Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Huang Yining, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Shanghai Hua Shan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.

Reference Type DERIVED
PMID: 35833913 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Neurology-2008-VD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cilostazol and Aspirin in Stroke and TIA
NCT06522113 COMPLETED PHASE4
Cilostazol for Prevention of Recurrent Stroke Trial
NCT07174414 NOT_YET_RECRUITING PHASE3