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

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ClinicalTrials.gov Identifier: NCT00847860
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : May 6, 2015
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Stroke Drug: Cilostazol Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
Study Start Date : March 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: 1
Drug: Cilostazol
Cilostazol 100 mg bid for 12 months

Active Comparator: 2
Drug: Aspirin
Aspirin 100 mg qd for 12 months

Primary Outcome Measures :
  1. changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth [ Time Frame: one year ]

Secondary Outcome Measures :
  1. stroke recurrence, other vascular ischemic events, bleeding events [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847860

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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Shanghai
Shanghai Hua Shan Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Peking University First Hospital
Zhejiang Otsuka Pharmaceutical Co., Ltd.
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Principal Investigator: Huang Yining, MD PhD Peking University First Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yining Huang, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00847860    
Other Study ID Numbers: Neurology-2008-VD
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: December 2009
Keywords provided by Peking University First Hospital:
Additional relevant MeSH terms:
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Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors