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Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

Information source: Inha University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Small Vessel Disease

Intervention: aspirin (Drug); cilostazol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Inha University Hospital

Official(s) and/or principal investigator(s):
Seong H. Choi, MD, PhD, Principal Investigator, Affiliation: Inha University Hospital

Overall contact:
Seong H. Choi, MD, PhD, Phone: 82 32 890 3659, Email: seonghye@inha..ac.kr

Summary

There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebal small vessel disease.

Clinical Details

Official title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease

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

Primary outcome: Volume of white matter changes (WMCs)

Secondary outcome:

Mean diffusivity and Fraction Anisotrophy on Diffusion Tensor Imaging

Number of lacunes

number of microbleeds

brain volume and cortical thickness

Mini-Mental State Examination

Neurocognitive test

Clinical Dementia Rating scale

King's Health Questionnaire

Geriatric Depression Scale-Short form

Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)

Bayer Activities of Daily Living

Barthel Index

Pyramidal and Extrapyramidal Scale (PEPS)

Timed UP and Go (TUG) test

Adverse event

Detailed description: The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease. The secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living. We also investigate risk factors associated with progression of cerebral small vessel disease.

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 50 to 85 years of age

- He/She can walk to the hospital (walker or cane is permissible).

- Cerebral small vessel disease is oberved on brain MRI.

1) presence of one or more lacunar infarction and 2) moderate or severe confluenct leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs >10 mm in maximum diameter

- written informed consent

Exclusion Criteria:

- Any patient with contraindication of antiplatelets

- Any patient with cardioembolic source

- Carotid bruit or large cerebral artery stenosis >50%

- Cortical infarction or subcortical infarction lager than 1. 5 cm

- bleeding tendency

- chronic liver disease (AST or ALT >100 IL/L)

- chronic renal disease (Creatinine >3. 0mg/dL)

- active gastrointestinal ulcer

- any patients with any severe or unstable medical disease that may prevent them from

completing study requirements (i. e., unstable or severe asthma)

- Anemia (Hb <10g/dL) or thrombocytopenia

- Cardiac pacemaker or contraindication to MRI

- Pregnancy or breast-feeding

- drug or alcohol addiction

- Any other white matte disease (i. e., Multiple sclerosis, sarcoidosis, or brain

irradiation, etc) or brain tumor

- Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease

- any hearing or visual impairment that can disturb the efficient evaluation of the

patient

- recent cerebral infarction with 3 months

Locations and Contacts

Seong H. Choi, MD, PhD, Phone: 82 32 890 3659, Email: seonghye@inha..ac.kr

Hallym University Medical Center, Anyang, Korea, Republic of; Not yet recruiting
Mi S. Oh, MD
Mi S. Oh, MD, Principal Investigator

Bucheon St.Mary's Hospital, Bucheon, Korea, Republic of; Not yet recruiting
Yong S. Shim, MD
Yong S. Shim, MD, Principal Investigator

Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of; Not yet recruiting
Sun A. Park, MD
Sun A. Park, MD, Principal Investigator

Konyang University Hospital, Daejeon, Korea, Republic of; Not yet recruiting
Bora Yoon, MD
Bora Yoon, MD, Principal Investigator

Chonnam National University Hospital, Gwangju, Korea, Republic of; Not yet recruiting
Byeong C. Kim, MD
Byeong C. Kim, MD, Principal Investigator

Gachon University Gil Medical, Incheon, Korea, Republic of; Not yet recruiting
Kee H. Park, MD
Kee H. Park, MD, Principal Investigator

Inha University Hospital, Incheon 400-711, Korea, Republic of; Recruiting
Seong H Choi, MD, PhD, Phone: 82 32 890 3659, Email: seonghye@inha.ac.kr
Seong H. Choi, MD, PhD, Principal Investigator

Dong-A University Hospital, Pusan, Korea, Republic of; Not yet recruiting
Kyung W. Park, MD
Kyung W. Park, MD, Principal Investigator

Pusan National University Hospital, Pusan, Korea, Republic of; Not yet recruiting
Eun-Joo Kim, MD
Eun-Joo Kim, MD, Principal Investigator

Asan Medical Center, Seoul, Korea, Republic of; Not yet recruiting
Jae-Hong Lee, MD
Jae-Hong Lee, MD, Principal Investigator

Chungang University Hospital, Seoul, Korea, Republic of; Not yet recruiting
Young-Chul Yoon, MD
Young-Chul Yoon, MD, Principal Investigator

Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of; Not yet recruiting
Jee H. Jeong, MD
Jee H. Jeong, MD, Principal Investigator

Kyung Hee University Hospital, Seoul, Korea, Republic of; Not yet recruiting
Key C Park, MD
Key C. Park, MD, Principal Investigator

Samsung Medical Center, Seoul, Korea, Republic of; Not yet recruiting
Duk L. Na, MD
Duk L. Na, MD, Principal Investigator

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea, Republic of; Not yet recruiting
Dong-Won Yang, MD
Dong-Won Yang, MD, Principal Investigator

Ajou University Hospital, Suwon, Korea, Republic of; Not yet recruiting
So Y. Moon, MD
So Y. Moon, MD, Principal Investigator

Additional Information

Starting date: July 2013
Last updated: September 12, 2013

Page last updated: August 23, 2015

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