Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II - Full Text View

Sponsor:	Asan Medical Center
Collaborator:	Korea Otsuka International Asia Arab
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00130039

Purpose

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (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 magnetic resonance angiogram (MRA).

Condition	Intervention	Phase
Cerebral Infarction Atherosclerosis	Drug: clopidogrel Drug: Cilostazol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Cilostazol Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Number of Participants With Progression of Symptomatic Intracranial Stenosis [ Time Frame: 7 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI [ Time Frame: 7 months after treatment ] [ Designated as safety issue: No ]
Number of Participants With Stroke Events [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
Number of Participants With Overall Cardiovascular Events [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
Number of Patients With Ipsilateral Ischemic Stroke Rate [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: No ]
Numbers of Fatal or Major Bleeding Complications [ Time Frame: upto 7 months after randomization ] [ Designated as safety issue: Yes ]

Enrollment:	457
Study Start Date:	August 2005
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: cilostazol cilostazol 100mg bid plus placebo of clopidogrel	Drug: Cilostazol Cilostazol 100mg twice a day plus placebo of clopidogrel once a day Other Name: cilostazol produced by Korea Otsuka Pharmaceutical
Active Comparator: Clopidogrel clopidogrel 75mg qd and matching placebo of cilostazol	Drug: clopidogrel Clopidogrel 75mg once a day plus placebo of cilostazol twice a day Other Name: Plavix, produced by Sanofi-Aventis.

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 (magnetic resonance image) 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

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130039

Locations

Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Korea, Republic of
Konkuk Univ. Hospital
Seoul, Gwangjin-gu Hwayang-dong, Korea, Republic of, 143-729
Inje University Ilsan Paik Hospital
Goyang, Gyeonggi-do, Korea, Republic of, 411-706
Dongguk University International Hospital
Goyang, Kyoungki-do, Korea, Republic of, 410-773
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, Korea, Republic of, 430-070
Inha University Hospital
Inchon, Korea, Republic of, 400-103
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji Hospital
Seoul, Korea, Republic of, 280-1
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kangdong Sacred Heart Hospital, Hallym University
Seoul, Korea, Republic of, 134-701
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-743
Philippines
University of Santo Tomas Hospital
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Thailand
Siriraj Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand

Sponsors and Collaborators

Asan Medical Center

Korea Otsuka International Asia Arab

Investigators

Principal Investigator:

Sun U. Kwon, MD, PhD

Asan Medical Center, Univsersity of Ulsan, Medical College

More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kwon SU, Hong KS, Kang DW, Park JM, Lee JH, Cho YJ, Yu KH, Koo JS, Wong KS, Lee SH, Lee KB, Kim DE, Jeong SW, Bae HJ, Lee BC, Han MK, Rha JH, Kim HY, Mok VC, Lee YS, Kim GM, Suwanwela NC, Yun SC, Nah HW, Kim JS. Efficacy and safety of combination antiplatelet therapies in patients with symptomatic intracranial atherosclerotic stenosis. Stroke. 2011 Oct;42(10):2883-90. Epub 2011 Jul 28.

Responsible Party:	Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00130039 History of Changes
Other Study ID Numbers:	TOSS-2
Study First Received:	August 11, 2005
Results First Received:	October 23, 2009
Last Updated:	January 4, 2010
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:

Infarction, Cerebral
cilostazol
stenosis
atherosclerosis
clopidogrel

Additional relevant MeSH terms:

Atherosclerosis
Cerebral Infarction
Stroke
Constriction, Pathologic
Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Cilostazol
Ticlopidine
Clopidogrel
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012