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Clinical Trials/NCT00847860
NCT00847860CompletedPhase 4

Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

Peking University First Hospital2 sites in 1 country200 target enrollmentStarted: March 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Cilostazol

Intervention: Cilostazol (Drug)

2

Active Comparator

Asprin

Intervention: Aspirin (Drug)

Outcomes

Primary Outcomes

changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth

Time Frame: one year

Secondary Outcomes

  • stroke recurrence, other vascular ischemic events, bleeding events(one year)

Investigators

Sponsor Class
Other

Study Sites (2)

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