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Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring cilostazol, aspirin, cerebral infarction

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Inje University Ilsan Paik Hospital
  • Seoul National University Bundang Hospital
  • Eulji University Hospital
  • Inha University Hospital
  • Dongguk University Hospital
  • Seoul National University Hospital
  • Hallym University Kangdong Sacred Heart Hospital
  • Asan Medical Center
  • Eulji University Hospital
  • Seoul National University Boramae Hospital
  • Soonchunhyang University Hospital

Outcomes

Primary Outcome Measures

Comparison of the frequency of mRS 0, 1, 2 at 90 days

Secondary Outcome Measures

Frequency of mRS 0,1 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)

Full Information

First Posted
January 3, 2006
Last Updated
December 15, 2009
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborators
Seoul National University Boramae Hospital, Korea Otsuka International Asia Arab Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00272454
Brief Title
Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
Official Title
The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborators
Seoul National University Boramae Hospital, Korea Otsuka International Asia Arab Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
cilostazol, aspirin, cerebral infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Comparison of the frequency of mRS 0, 1, 2 at 90 days
Time Frame
at 90 days
Secondary Outcome Measure Information:
Title
Frequency of mRS 0,1 at 90 days
Time Frame
at 90 days
Title
Frequency of Barthel index 95-100 at 90 days
Title
Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Title
Frequency of NIHSS 0-1 at 90 days
Title
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)
Title
Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
Title
Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Seok Lee, M.D., PhD
Organizational Affiliation
Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Ahnyang
State/Province
Kyunggi Province
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Koyang
State/Province
Kyunggi Province
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
State/Province
Kyunggi Province
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Dongguk University Hospital
City
Koyang, Kyunggi Province
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Seoul
ZIP/Postal Code
139-711
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21613787
Citation
Lee YS, Bae HJ, Kang DW, Lee SH, Yu K, Park JM, Cho YJ, Hong KS, Kim DE, Kwon SU, Lee KB, Rha JH, Koo J, Han MG, Lee SJ, Lee JH, Jung SW, Lee BC, Kim JS. Cilostazol in Acute Ischemic Stroke Treatment (CAIST Trial): a randomized double-blind non-inferiority trial. Cerebrovasc Dis. 2011;32(1):65-71. doi: 10.1159/000327036. Epub 2011 May 25.
Results Reference
derived

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Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

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