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

Phase 4

Completed

• Conditions: Vascular Dementia; Stroke
• Interventions: Drug: Aspirin; Drug: Cilostazol

• Registration Number: NCT00847860
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Status Verified: 2009-12
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Aspirin	Asprin
1	Cilostazol	Cilostazol

Primary Outcome Measures

Name	Time	Method
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth	one year

Secondary Outcome Measures

Name	Time	Method
stroke recurrence, other vascular ischemic events, bleeding events	one year

Trial Locations

Locations (2)

Shanghai Hua Shan Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China