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Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
This study has been completed.

First Received on January 3, 2006.   Last Updated on December 15, 2009   History of Changes
Sponsor: Korea Otsuka Pharmaceutical Co.,Ltd.
Collaborators: Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.
Information provided by: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00272454
  Purpose

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


Condition Intervention Phase
Cerebral Infarction
Drug: Cilostazol
Drug: Aspirin
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

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

Secondary Outcome Measures:
  • Frequency of mRS 0,1 at 90 days [ Time Frame: at 90 days ]
  • Frequency of Barthel index 95-100 at 90 days
  • Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
  • Frequency of NIHSS 0-1 at 90 days
  • 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)
  • Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
  • Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)

Estimated Enrollment: 468
Study Start Date: January 2006
Study Completion Date: September 2008
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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272454

Locations
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
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Soonchunhyang University Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji University Hospital
Seoul, Korea, Republic of, 139-711
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.
Investigators
Principal Investigator: Yong-Seok Lee, M.D., PhD Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
  More Information

No publications provided by Korea Otsuka Pharmaceutical Co.,Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00272454     History of Changes
Obsolete Identifiers: NCT00272129
Other Study ID Numbers: KOP-PLT-0501
Study First Received: January 3, 2006
Last Updated: December 15, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
cilostazol
aspirin
cerebral infarction

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 13, 2012