Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II (TOSS-2)

This study has been completed.
Sponsor:
Collaborator:
Korea Otsuka International Asia Arab
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00130039
First received: August 11, 2005
Last updated: January 4, 2010
Last verified: November 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales 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
Kangdong Sacred Heart Hospital, Hallym University
Seoul, Korea, Republic of, 134-701
Eulji Hospital
Seoul, Korea, Republic of, 280-1
Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-743
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Philippines
University of Santo Tomas Hospital
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj 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):
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:
Arteriosclerosis
Atherosclerosis
Cerebral Infarction
Infarction
Stroke
Arterial Occlusive Diseases
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Cilostazol
Clopidogrel
Ticlopidine
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 29, 2014