Cilostazol Verse Asprin for Vascular Dementia in Poststro... | NCT00847860

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

NCT00847860

Sponsor

Peking University First Hospital

Status

Completed

Last Update Posted

May 6, 2015Estimated

Enrollment

200Actual

Phase

Phase 4

Conditions

Vascular Dementia
Stroke

Interventions

Cilostazol
Aspirin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

May 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Name	Class
Zhejiang Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cilostazol	Drug: Cilostazol
2	Active Comparator	Asprin	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cilostazol	Drug	Cilostazol 100 mg bid for 12 months	1
Aspirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth		one year

Secondary Outcomes

Measure	Description	Time Frame
stroke recurrence, other vascular ischemic events, bleeding events		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Huang Yining, MD PhD	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality	100034	China
Shanghai Hua Shan Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35833913	Derived	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.

ID	Term
D015140	Dementia, Vascular
D020521	Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds