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

• Sponsor: Peking University First Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00847860
• Collaborator: Zhejiang Otsuka Pharmaceutical Co., Ltd. (Industry)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 100
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Dementia; Stroke	Drug: Cilostazol; Drug: Aspirin	Phase 4

Study Design

• Study Type: Interventional
• 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: Mar 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth [one year]

Secondary Outcome Measures

1. stroke recurrence, other vascular ischemic events, bleeding events [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034
2	Shanghai Hua Shan Hospital	Shanghai	Shanghai	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00847860
• Other Study ID Numbers: Neurology-2008-VD
• First Posted: Feb 19, 2009
• Last Update Posted: May 6, 2015
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: cognition
• Additional relevant MeSH terms: Dementia; Dementia, Vascular; Aspirin; Cilostazol

Study Results

No Results Posted as of May 6, 2015