Back to resultsCilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions (CAVAD)
Primary Purpose
Vascular Dementia, Stroke
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring cognition
Eligibility Criteria
Inclusion Criteria:
- Age ranging from 40 to 80 years
- After newly ischemic stroke from 3 months to 2 years
- Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4
- Moderate or mild cognitive deficits: MMSE 12-26
- Vascular or mixed dementia: Hachinski ischemic score>4
- Moderate or mild disability: MRS<=4,NIHSS<20
- Informed consent
Exclusion Criteria:
- Definitive diagnosis of dementia prior to the stroke
- Cerebral hemorrhage in the past
- Cerebral embolism result from cardiogenic embolus
- Critically ills: MRS>4,NIHSS>=20
- Bed-ridden patient who is hardly discovered newly stroke
- patient with sever cardiac, hepatic or nephric complication
- dementia caused not by vascular lesions
- other diseases disturb the cognitive evaluation
- susceptibility to varieties of allergen
- abstain from Cilostazol or Asprin
- antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
- rejected to participate by the patient or the family
Sites / Locations
- Peking University First Hospital
- Shanghai Hua Shan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cilostazol
Asprin
Outcomes
Primary Outcome Measures
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Secondary Outcome Measures
stroke recurrence, other vascular ischemic events, bleeding events
Full Information
NCT ID
NCT00847860
First Posted
February 17, 2009
Last Updated
May 5, 2015
Sponsor
Peking University First Hospital
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00847860
Brief Title
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
Acronym
CAVAD
Official Title
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University First Hospital
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia, Stroke
Keywords
cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cilostazol
Arm Title
2
Arm Type
Active Comparator
Arm Description
Asprin
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
Cilostazol 100 mg bid for 12 months
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 100 mg qd for 12 months
Primary Outcome Measure Information:
Title
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Time Frame
one year
Secondary Outcome Measure Information:
Title
stroke recurrence, other vascular ischemic events, bleeding events
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ranging from 40 to 80 years
After newly ischemic stroke from 3 months to 2 years
Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4
Moderate or mild cognitive deficits: MMSE 12-26
Vascular or mixed dementia: Hachinski ischemic score>4
Moderate or mild disability: MRS<=4,NIHSS<20
Informed consent
Exclusion Criteria:
Definitive diagnosis of dementia prior to the stroke
Cerebral hemorrhage in the past
Cerebral embolism result from cardiogenic embolus
Critically ills: MRS>4,NIHSS>=20
Bed-ridden patient who is hardly discovered newly stroke
patient with sever cardiac, hepatic or nephric complication
dementia caused not by vascular lesions
other diseases disturb the cognitive evaluation
susceptibility to varieties of allergen
abstain from Cilostazol or Asprin
antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
rejected to participate by the patient or the family
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Yining, MD PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Shanghai Hua Shan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35833913
Citation
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.
Results Reference
derived
Learn more about this trial
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
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