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

May 5, 2015 updated by: Peking University First Hospital

Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cilostazol
Drug: Cilostazol
Cilostazol 100 mg bid for 12 months
Active Comparator: 2
Asprin
Drug: Aspirin
Aspirin 100 mg qd for 12 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Zhejiang Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Huang Yining, MD PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurology-2008-VD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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