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Sponsors and Collaborators: |
Korea Otsuka Pharmaceutical Co.,Ltd. Seoul National University Boramae Hospital Korea Otsuka International Asia Arab Co., Ltd. |
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Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00272454 |
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.
Ages Eligible for Study: | 30 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | KOP-PLT-0501 |
Study First Received: | January 3, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00272454 |
Health Authority: | South Korea: Institutional Review Board |
cilostazol aspirin cerebral infarction |
Cilostazol Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Necrosis Aspirin Brain Ischemia Brain Infarction Infarction |
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Neuroprotective Agents Fibrin Modulating Agents Pathologic Processes Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics |
Nervous System Diseases Cyclooxygenase Inhibitors Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Analgesics, Non-Narcotic Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Bronchodilator Agents |