Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions - Full Text View

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

This study is currently recruiting participants.

Verified by Peking University First Hospital, February 2009

First Received: February 17, 2009 No Changes Posted

Sponsors and Collaborators:	Peking University First Hospital Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Peking University First Hospital
ClinicalTrials.gov Identifier:	NCT00847860

Purpose

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	Intervention	Phase
Vascular Dementia Stroke	Drug: Cilostazol Drug: Aspirin	Phase IV

MedlinePlus related topics: Dementia

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:

changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

stroke recurrence, other vascular ischemic events, bleeding events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cilostazol	Drug: Cilostazol Cilostazol 100 mg bid for 12 months
2: Active Comparator Asprin	Drug: Aspirin Aspirin 100 mg qd for 12 months

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847860

Contacts

Contact: Yining Huang, MD PhD

8610-66551122 ext 2857

ynhuang@sina.com

Locations

China
Peking University First Hospital	Recruiting
Beijing, China, 100034
Contact: Yining Huang, MD PhD 8610-66551122 ext 2857 ynhuang@sina.com
Principal Investigator: Yining Huang, MD PhD
China, Shang Hai
Shanghai Hua Shan Hospital	Recruiting
Shanghai, Shang Hai, China, 200040
Contact: Chuanzhen lv, MD PhD 13012866280
Sub-Investigator: Zhen Hong, MD

Sponsors and Collaborators

Peking University First Hospital

Zhejiang Otsuka Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Huang Yining, MD PhD

Peking University First Hospital

More Information

No publications provided

Responsible Party:	Peking University First Hospital ( Yining Huang )
Study ID Numbers:	Neurology-2008-VD
Study First Received:	February 17, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00847860 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Peking University First Hospital:

cognition

Study placed in the following topic categories:

Vasodilator Agents
Cerebral Infarction
Fibrinolytic Agents
Arteriosclerosis
Brain Diseases
Neuroprotective Agents
Intracranial Arterial Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Fibrin Modulating Agents
Aspirin
Mental Disorders
Dementia, Vascular
Dementia

Delirium
Arterial Occlusive Diseases
Cilostazol
Stroke
Vascular Diseases
Central Nervous System Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Arteriosclerosis
Brain Diseases
Neuroprotective Agents
Intracranial Arterial Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Fibrin Modulating Agents
Mental Disorders
Therapeutic Uses

Dementia, Vascular
Cardiovascular Diseases
Dementia
Arterial Occlusive Diseases
Cilostazol
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on May 07, 2009