Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
Information source: Peking University First Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vascular Dementia; Stroke
Intervention: Cilostazol (Drug); Aspirin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Peking University First Hospital Official(s) and/or principal investigator(s):
Huang Yining, MD PhD, Principal Investigator, Affiliation: Peking University First Hospital
Overall contact:
Yining Huang, MD PhD, Phone: 8610-66551122, Ext: 2857, Email: ynhuang@sina.com
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.
Clinical Details
Official title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Primary outcome: changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Secondary outcome: stroke recurrence, other vascular ischemic events, bleeding events
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Yining Huang, MD PhD, Phone: 8610-66551122, Ext: 2857, Email: ynhuang@sina.com
Peking University First Hospital, Beijing 100034, China; Recruiting
Yining Huang, MD PhD, Phone: 8610-66551122, Ext: 2857, Email: ynhuang@sina.com
Yining Huang, MD PhD, Principal Investigator
Shanghai Hua Shan Hospital, Shanghai, Shang Hai 200040, China; Recruiting
Chuanzhen lv, MD PhD, Phone: 13012866280
Zhen Hong, MD, Sub-Investigator
Additional Information
Starting date: March 2008
Ending date: June 2010
Last updated: February 17, 2009
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