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Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction; Atherosclerosis

Intervention: clopidogrel (Drug); Cilostazol (Drug)

Phase: Phase 4

Status: Completed

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

Summary

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).

Clinical Details

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

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

Primary outcome: Number of Participants With Progression of Symptomatic Intracranial Stenosis

Secondary outcome:

Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI

Number of Participants With Stroke Events

Number of Participants With Overall Cardiovascular Events

Number of Patients With Ipsilateral Ischemic Stroke Rate

Numbers of 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 (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

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

Locations and Contacts

Prince of Wales Hospital, Hong Kong, Hong Kong

Queen Mary Hospital, Hong Kong, Hong Kong

Inha University Hospital, Inchon 400-103, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

Asan Medical Center, Seoul 138-736, Korea, Republic of

Eulji Hospital, Seoul 280-1, Korea, Republic of

Kangdong Sacred Heart Hospital, Hallym University, Seoul 134-701, Korea, Republic of

Samsung Medical Center, Seoul 135-710, Korea, Republic of

Seoul National University Boramae Hospital, Seoul 156-707, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Soonchunhyang University Hospital, Seoul 140-743, Korea, Republic of

Philippine General Hospital, Manila, Philippines

University of Santo Tomas Hospital, Manila, Philippines

Ramathibodi Hospital, Bangkok, Thailand

Siriraj Hospital, Bangkok, Thailand

Konkuk Univ. Hospital, Seoul, Gwangjin-gu Hwayang-dong 143-729, Korea, Republic of

Inje University Ilsan Paik Hospital, Goyang, Gyeonggi-do 411-706, Korea, Republic of

Dongguk University International Hospital, Goyang, Kyoungki-do 410-773, Korea, Republic of

Hallym University Sacred Heart Hospital, Anyang, Kyunggi 430-070, Korea, Republic of

Additional Information

Starting date: August 2005
Last updated: January 4, 2010

Page last updated: August 23, 2015

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