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CompletedNCT00847860CAVADUpdated May 6, 2015

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

A Phase 4 interventional study of Cilostazol and Aspirin in Vascular Dementia and Stroke, sponsored by Peking University First Hospital. Completed at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by Peking University First Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Dementia
  • Stroke

Keywords

  • cognition
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 200 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    1

    Cilostazol

    Drug: Cilostazol

  • Active comparator
    2

    Asprin

    Drug: Aspirin

Interventions

  • DrugCilostazol

    Cilostazol 100 mg bid for 12 months

  • DrugAspirin

    Aspirin 100 mg qd for 12 months

06

What researchers measure

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  1. stroke recurrence, other vascular ischemic events, bleeding events

    Time frame: one year

07

Study locations

2 sites
  • Peking University First Hospital
    Beijing, Beijing 100034, China
  • Shanghai Hua Shan Hospital
    Shanghai, Shanghai 200040, China
08

References and documents

Publications

  • 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. PubMed 35833913 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00847860
Lead sponsor
Peking University First Hospital
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.
First posted
Feb 19, 2009
Start date
Mar 2008
Primary completion
May 2011
Completion
Jun 2011
Last update
May 6, 2015

Study contacts

Huang Yining, MD PhD
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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