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Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00272454
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : December 16, 2009
Sponsor:
Collaborators:
Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Cilostazol Drug: Aspirin Phase 4

Detailed Description:

Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.

Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
Study Start Date : January 2006
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of the frequency of mRS 0, 1, 2 at 90 days [ Time Frame: at 90 days ]

Secondary Outcome Measures :
  1. Frequency of mRS 0,1 at 90 days [ Time Frame: at 90 days ]
  2. Frequency of Barthel index 95-100 at 90 days
  3. Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
  4. Frequency of NIHSS 0-1 at 90 days
  5. Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
  6. Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
  7. Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who receive explanation on this study and give informed consent
  • Patients aged 30 to 85 years
  • Baseline NIHSS less than 15
  • Onset of symptoms within 48 hours of the start of investigational product
  • Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2

Exclusion Criteria:

  • Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
  • Previous regular use of an antiplatelet agent or warfarin
  • Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
  • Evidence from CT or MRI scan of midline shift when visiting hospital
  • Uncontrolled hypertension (SBP>220 mmHg or DBP>120 mmHg)
  • Hypotension (<90/60 mmHg)
  • Patients with known bleeding diathesis or coagulation disorder
  • Patients with liver disease (ALT>100 or AST>100), or renal disease (creatinine>2.0 mg/dl)
  • Known severe anaemia (hemoglobin<8.0 mg/dl), or thrombocytopenia (platelet<100,000/mm3)
  • Scheduled for endarterectomy within 3 months
  • Severe co-morbidity likely to limit patient's life expectancy to less than 6 months
  • Patients with alcohol or illegal drug abuse or dependency
  • Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug.
  • Patients treated by thrombolytic agents like tPA after onset of stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272454


Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital
Ahnyang, Kyunggi Province, Korea, Republic of, 431-070
Inje University Ilsan Paik Hospital
Koyang, Kyunggi Province, Korea, Republic of, 411-706
Seoul National University Bundang Hospital
Sungnam, Kyunggi Province, Korea, Republic of, 463-707
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Dongguk University Hospital
Koyang, Kyunggi Province, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji University Hospital
Seoul, Korea, Republic of, 139-711
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Soonchunhyang University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.
Investigators
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Principal Investigator: Yong-Seok Lee, M.D., PhD Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00272454    
Obsolete Identifiers: NCT00272129
Other Study ID Numbers: KOP-PLT-0501
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009
Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
cilostazol
aspirin
cerebral infarction
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors