Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II

Condition(s) targeted: Cerebral Infarction; Atherosclerosis

Intervention: cilostazol versus clopidogrel (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Sun U. Kwon, MD, PhD, Principal Investigator, Affiliation: Asan Medical Center, Univsersity of Ulsan, Medical College

Overall contact:
Sun U Kwon, MD, PhD, Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of MCA or basilar artery).

They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally.

The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on MRA.

Official title: Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Progression rate of symptomatic intracranial stenosis

Secondary outcome:

The occurrence of new MRI lesion on follow-up MRI

Stroke events

Overall cardiovascular events: stroke, acute coronary syndrome, vascular death

Ipsilateral ischemic stroke rate

Fatal or major bleeding complications

Detailed description: [Goal] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis.

[Trial Design] Double-Blind, Active-Controlled, Randomized, Multicenter Trial

[Participants] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis

[Methods]

- Double-Blind, Active-Controlled, Randomized, Multicenter Trial

- Investigational product (Double Dummy Method):

Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg

- Concomitant medication: Aspirin 100 (75-150) mg per day

- Medication Duration: 7 months

[Outcome Variables]

Primary Outcome Variable:

- Progression rate of symptomatic intracranial arterial stenosis

Secondary outcome variables:

- The occurrence of new MRI lesion on follow-up MRI

- Stroke events

- Overall cardiovascular events: stroke, acute coronary syndrome, vascular death

- Ipsilateral ischemic stroke rate

- Fatal or major bleeding complications

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute

ischemic brain lesions on MRI within 2 weeks from the onset

- Age: more than 35 years of age

- Patient with significant focal stenosis in the M1 segment of middle cerebral artery

(MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery.

Exclusion Criteria:

- Patients with any contraindications to the treatment with antiplatelet therapy

- Patients with potential cardiac embolic source; prosthetic valve, atrial

fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)

- Patients with more than 50% stenosis in the parent artery of symptomatic stenosis

- Bleeding diathesis

- Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine >

3. 0mg/dl)

- Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than

100,000/mm3)

- Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting

arterial dissection, moyamoya disease, Takayasu’s arteritis, radiation associated angiopathy, and other vasculitis.

- Severe stroke: NIH stroke scale : more than 16

- Pregnant or lactating patients

- Chronic user of NSAIDs

- Thrombolytic therapy for the symptomatic stenosis

- Symptomatic stenosis scheduled for angioplasty

- Patients with pacemaker or any other contraindications to MRI

Sun U Kwon, MD, PhD, Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr

Prince of Wales Hospital, Hong Kong, Hong Kong; Recruiting
Vincent CT Mok, MD, Email: vctmok@cuhk.edu.hk

Queen Mary Hospital, Hong Kong, Hong Kong; Recruiting
Raymond TF Cheung, MD, PhD, Email: rtcheung@hkucc.hku.hk

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Sun U. Kwon, MD, PhD, Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr
Jong S Kim, MD, PhD, Sub-Investigator
Dong W Kang, MD, PhD, Sub-Investigator

Eulji Hospital, Seoul 280-1, Korea, Republic of; Recruiting
Ja-Seong Koo, MD, Phone: 82-2-970-8609, Email: kjs1406@eulji.or.kr
Jong-Moo Park, MD, Sub-Investigator

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting
Gyeong-Moon Kim, M.D., Phone: 82-2-3410-3598, Email: kimgm@smc.samsung.co.kr

Inha University Hospital, Inchon 400-103, Korea, Republic of; Recruiting
Joung-Ho Rha, MD, Phone: +82-32-890-3668, Email: jhrha@inha.ac.kr
Joung-Ho Rha, MD, Principal Investigator

Kangdong Sacred Heart Hospital, Hallym University, SEOUL 134-701, Korea, Republic of; Recruiting
Ju-Hun Lee, Phone: 82-2-2224-2695, Email: leeforte@medimail.co.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Seung-Hoon Lee, Prof., Phone: 82-2-2072-1014, Email: sb0516@snu.ac.kr

Seoul National University Bundang Hospital, Sungnam, Korea, Republic of; Recruiting
Moon-Ku Han, MD, Phone: 82-31-787-7464, Email: blue4han@chollian.net
Hee-Joon Bae, MD, Ph.D, Sub-Investigator

Seoul National University Boramae Hospital, Seoul 156-707, Korea, Republic of; Recruiting
Yong-Seok Lee, MD, Phone: 82-2-840-2492, Email: lys@brm.co.kr

Soonchunhyang University Hospital, Seoul 140-743, Korea, Republic of; Recruiting
Kyung Bok Lee, M.D., Phone: +82-2-709-9262, Email: kblee@hosp.sch.ac.kr
Kyung Bok Lee, M.D., Principal Investigator

University of Santo Tomas Hospital, Manila, Philippines; Recruiting
Jose Navarro, Email: jc.navarro@icable.ph

Philippine General Hospital, Manila, Philippines; Recruiting
Cristina San Jose, Email: czsanjose@yahoo.com

Siriraj Hospital, Bangkok, Thailand; Recruiting
Niphon Poungvarin, M.D., Email: sinpg@mahidol.ac.th

Ramathibodi Hospital, Bangkok, Thailand; Recruiting
Disya Ratanakorn, M.D., Email: radrt@mahidol.ac.th

Konkuk Univ. Hospital, Seoul, Gwangjin-gu Hwayang-dong 143-729, Korea, Republic of; Recruiting
Hahn Young Kim, Phone: 82-2-2030-7563, Email: drdpl@freechal.com
Hahn Young Kim, MD, Principal Investigator

Inje University Ilsan Paik Hospital, Goyang, Gyeonggi-do 411-706, Korea, Republic of; Recruiting
Keun-Sik Hong, MD/PhD, Phone: 82-31-910-7680, Email: nrhks@ilsanpaik.ac.kr
Yong-Jin Cho, MD, PhD, Sub-Investigator

Dongguk University International Hospital, Goyang, Kyoungki-do 410-773, Korea, Republic of; Recruiting
Dong-Eog Kim, MD, PhD, Phone: 031-961-7200, Email: kdongeog@duih.org
Dong-Eog Kim, MD, PhD, Principal Investigator
Sang-Wook Jeong, MD, PhD, Sub-Investigator

Hallym University Sacred Heart Hospital, Anyang, Kyunggi 430-070, Korea, Republic of; Recruiting
Byung-Chul Lee, MD. PhD., Phone: +82-31-380-3741, Email: ssbrain@hallym.ac.kr
Kyung-Ho Yu, MD., Phone: +82-31-380-3743, Email: ykh1030@hallym.or.kr
Byung-Chul Lee, MD. PhD., Sub-Investigator
Kyung-Ho Yu, MD., Principal Investigator

webpage for review of the case eligibility and randomization. It shows also the basic statistical data for the current enrollment

Starting date: August 2005
Ending date: December 2008
Last updated: March 12, 2007