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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| 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 | |
| Hallym University Sacred Heart Hospital | |
| Ahnyang, Kyunggi Province, Korea, Republic of, 431-070 | |
| Inje University Ilsan Paik Hospital | |
| Koyang, Kyunggi Province, Korea, Republic of, 411-706 | |
| Seoul National University Bundang Hospital | |
| Sungnam, Kyunggi Province, Korea, Republic of, 463-707 | |
| Eulji University Hospital | |
| Daejeon, Korea, Republic of, 302-799 | |
| Inha University Hospital | |
| Incheon, Korea, Republic of, 400-711 | |
| Dongguk University Hospital | |
| Koyang, Kyunggi Province, Korea, Republic of | |
| Hallym University Kangdong Sacred Heart Hospital | |
| Seoul, Korea, Republic of, 134-701 | |
| Seoul National University Boramae Hospital | |
| Seoul, Korea, Republic of, 156-707 | |
| Soonchunhyang University Hospital | |
| Seoul, Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-799 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Eulji University Hospital | |
| Seoul, Korea, Republic of, 139-711 | |
| Principal Investigator: | Yong-Seok Lee, M.D., PhD | Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University |
More Information
| ClinicalTrials.gov Identifier: | NCT00272454 History of Changes |
| Obsolete Identifiers: | NCT00272129 |
| Other Study ID Numbers: | KOP-PLT-0501 |
| Study First Received: | January 3, 2006 |
| Last Updated: | December 15, 2009 |
| Health Authority: | South Korea: Institutional Review Board |
|
cilostazol aspirin cerebral infarction |
|
Cerebral Infarction Stroke Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Aspirin |
Cilostazol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |