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Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Information source: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction

Intervention: Cilostazol (Drug); Aspirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Korea Otsuka Pharmaceutical Co.,Ltd.

Official(s) and/or principal investigator(s):
Yong-Seok Lee, M.D., PhD, Principal Investigator, Affiliation: Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University


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

Clinical Details

Official title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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)

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.


Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.


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


- Known severe anaemia (hemoglobin<8. 0 mg/dl), or thrombocytopenia


- 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

Locations and Contacts

Eulji University Hospital, Daejeon 302-799, Korea, Republic of

Inha University Hospital, Incheon 400-711, Korea, Republic of

Dongguk University Hospital, Koyang, Kyunggi Province, Korea, Republic of

Asan Medical Center, Seoul 138-736, Korea, Republic of

Eulji University Hospital, Seoul 139-711, Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital, Seoul 134-701, Korea, Republic of

Seoul National University Boramae Hospital, Seoul 156-707, Korea, Republic of

Seoul National University Hospital, Seoul 110-799, Korea, Republic of

Soonchunhyang University Hospital, Seoul, Korea, Republic of

Hallym University Sacred Heart Hospital, Ahnyang, Kyunggi Province 431-070, Korea, Republic of

Inje University Ilsan Paik Hospital, Koyang, Kyunggi Province 411-706, Korea, Republic of

Seoul National University Bundang Hospital, Sungnam, Kyunggi Province 463-707, Korea, Republic of

Additional Information

Starting date: January 2006
Last updated: December 15, 2009

Page last updated: August 23, 2015

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