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

This study has been completed.
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Peking University First Hospital Identifier:
First received: February 17, 2009
Last updated: May 5, 2015
Last verified: December 2009
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 Intervention Phase
Vascular Dementia
Drug: Cilostazol
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

Resource links provided by NLM:

Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • stroke recurrence, other vascular ischemic events, bleeding events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Cilostazol
Cilostazol 100 mg bid for 12 months
Active Comparator: 2
Drug: Aspirin
Aspirin 100 mg qd for 12 months


Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00847860

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.
Principal Investigator: Huang Yining, MD PhD Peking University First Hospital
  More Information

Responsible Party: Yining Huang, Peking University First Hospital Identifier: NCT00847860     History of Changes
Other Study ID Numbers: Neurology-2008-VD 
Study First Received: February 17, 2009
Last Updated: May 5, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:

Additional relevant MeSH terms:
Dementia, Vascular
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Mental Disorders
Nervous System Diseases
Vascular Diseases
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors processed this record on April 27, 2016