Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Phase 4

Completed

• Conditions: Cerebral Infarction

• Registration Number: NCT00272454
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-06
• Study Completion: 2008-09
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-15
• Last Update Posted: 2009-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (11)

Hallym University Sacred Heart Hospital; 🇰🇷 Ahnyang, Kyunggi Province, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Koyang, Kyunggi Province, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sungnam, Kyunggi Province, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Dongguk University Hospital; 🇰🇷 Koyang, Kyunggi Province, Korea, Republic of

Eulji University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of