Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272454
• Other study ID #: KOP-PLT-0501
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2006
• Last updated: December 15, 2009
• Start date: January 2006
• Est. completion date: September 2008

Study information

• Verified date: December 2009
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00272129

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Cilostazol

• Aspirin

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Ahnyang	Kyunggi Province
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Inje University Ilsan Paik Hospital	Koyang	Kyunggi Province
Korea, Republic of	Dongguk University Hospital	Koyang, Kyunggi Province
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji 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	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam	Kyunggi Province

Sponsors (3)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.	Korea Otsuka International Asia Arab Co., Ltd., Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the frequency of mRS 0, 1, 2 at 90 days		at 90 days
Secondary	Frequency of mRS 0,1 at 90 days		at 90 days
Secondary	Frequency of Barthel index 95-100 at 90 days
Secondary	Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Secondary	Frequency of NIHSS 0-1 at 90 days
Secondary	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)
Secondary	Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
Secondary	Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)