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

Stroke Clinical Trial

— CAVAD  

Official title:

Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847860
• Other study ID #: Neurology-2008-VD
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2009
• Last updated: May 5, 2015
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Stroke
• Vascular Dementia

Intervention

Drug:
• Cilostazol
Cilostazol 100 mg bid for 12 months
• Aspirin
Aspirin 100 mg qd for 12 months

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Shanghai Hua Shan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Zhejiang Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth		one year	No
Secondary	stroke recurrence, other vascular ischemic events, bleeding events		one year	Yes