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| Sponsor: | Korea Otsuka Pharmaceutical Co.,Ltd. |
|---|---|
| Collaborators: |
Seoul National University Boramae Hospital Korea Otsuka International Asia Arab Co., Ltd. |
| Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT00272454 |
Purpose
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Infarction |
Drug: Cilostazol Drug: Aspirin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke |
| Estimated Enrollment: | 468 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | September 2008 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Korea, Republic of | |
| Seoul National University Boramae Hospital | |
| Seoul, Korea, Republic of, 156-707 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Eulji University Hospital | |
| Seoul, Korea, Republic of, 139-711 | |
| Inha University Hospital | |
| Incheon, Korea, Republic of, 400-711 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-799 | |
| Eulji University Hospital | |
| Daejeon, Korea, Republic of, 302-799 | |
| Kangdong Sacred Heart Hospital | |
| Seoul, Korea, Republic of, 134-701 | |
| Korea, Republic of, Kyunggi Province | |
| Seoul National University Bundang Hospital | |
| Sungnam, Kyunggi Province, Korea, Republic of, 463-707 | |
| Hallym University Sacred Heart Hospital | |
| Ahnyang, Kyunggi Province, Korea, Republic of, 431-070 | |
| Ilsan Paik Hospital | |
| Koyang, Kyunggi Province, Korea, Republic of, 411-706 | |
| Principal Investigator: | Yong-Seok Lee, M.D., PhD | Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University |
More Information
| Study ID Numbers: | KOP-PLT-0501 |
| Study First Received: | January 3, 2006 |
| Last Updated: | May 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00272454 History of Changes |
| Health Authority: | South Korea: Institutional Review Board |
|
cilostazol aspirin cerebral infarction |
|
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Brain Diseases Neuroprotective Agents Cerebrovascular Disorders Fibrin Modulating Agents Necrosis Pathologic Processes Aspirin |
Sensory System Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Cilostazol Cyclooxygenase Inhibitors Nervous System Diseases Stroke Vascular Diseases Anti-Asthmatic Agents Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents |