Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

December 15, 2009 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

468

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 302-799
        • Eulji University Hospital
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Koyang, Kyunggi Province, Korea, Republic of
        • Dongguk University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 156-707
        • Seoul National University Boramae Hospital
      • Seoul, Korea, Republic of, 134-701
        • Hallym University Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of, 110-799
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 139-711
        • Eulji University Hospital
    • Kyunggi Province
      • Ahnyang, Kyunggi Province, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital
      • Koyang, Kyunggi Province, Korea, Republic of, 411-706
        • Inje University Ilsan Paik Hospital
      • Sungnam, Kyunggi Province, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of mRS 0,1 at 90 days
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Collaborators

Seoul National University Boramae Hospital
Korea Otsuka International Asia Arab Co., Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 6, 2006

Study Record Updates

Last Update Posted (Estimate)

December 16, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOP-PLT-0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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