Cilostazol in Acute Ischemic Stroke Treatment (CAIST) | NCT00272454

Studies
Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

NCT00272454

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 16, 2009Estimated

Enrollment

468Estimated

Phase

Phase 4

Conditions

Cerebral Infarction

Interventions

Cilostazol
Aspirin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Sep 2008Actual

First Submitted Date

Jan 3, 2006

First Submission Date that Met QC Criteria

Jan 5, 2006

First Posted Date

Jan 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2009

Last Update Posted Date

Dec 16, 2009Estimated

Name	Class
Seoul National University Boramae Hospital	OTHER
Korea Otsuka International Asia Arab Co., Ltd.	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

468Estimated

Measure	Description	Time Frame
Comparison of the frequency of mRS 0, 1, 2 at 90 days		at 90 days

Measure	Description	Time Frame
Frequency of mRS 0,1 at 90 days		at 90 days
Frequency of Barthel index 95-100 at 90 days
Frequency of mRS 0,1 & Barthel index 95-100 at 90 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yong-Seok Lee, M.D., PhD	Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital		Ahnyang	Kyunggi Province	431-070	South Korea
Inje University Ilsan Paik Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21613787	Derived	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.

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
Cilostazol	Drug
Aspirin	Drug

ID	Term
D000077407	Cilostazol
D001241	Aspirin