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

This study has been completed.
Sponsor:
Collaborator:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT00847860
First received: February 17, 2009
Last updated: July 20, 2011
Last verified: December 2009
  Purpose

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
Stroke
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
Cilostazol
Drug: Cilostazol
Cilostazol 100 mg bid for 12 months
Active Comparator: 2
Asprin
Drug: Aspirin
Aspirin 100 mg qd for 12 months

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847860

Locations
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Shang Hai
Shanghai Hua Shan Hospital
Shanghai, Shang Hai, China, 200040
Sponsors and Collaborators
Peking University First Hospital
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Huang Yining, MD PhD Peking University First Hospital
  More Information

No publications provided

Responsible Party: Yining Huang, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00847860     History of Changes
Other Study ID Numbers: Neurology-2008-VD
Study First Received: February 17, 2009
Last Updated: July 20, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:
cognition

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on April 22, 2014