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Sponsors and Collaborators: |
Mitsubishi Tanabe Pharma Corporation Kyowa Hakko Kogyo Co., Ltd. |
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Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00147316 |
Based on previous studies comparing different rt-PA doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.
Condition | Intervention | Phase |
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Cerebral Infarction Brain Ischemia |
Drug: alteplase |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Japan Alteplase Clinical Trial(J-ACT): Phase 3 Efficacy and Safety Study of Tissue Plasminogen Activator for Acute Ischemic Stroke Within 3 Hours of Onset |
Estimated Enrollment: | 100 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | September 2003 |
Based on previous studies comparing different rt-PA doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese. The primary endpoints were the rate of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months and the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset
Exclusion Criteria:
patients with rapidly improving neurological symptoms or with minor neurological deficit (an NIHSS score of
heparin administration within 48 hours preceding stroke onset with an elevated activated partial thromboplastin time (APTT); current use of oral anticoagulants with an International Normalized Ratio (INR) of
Japan, Osaka | |
National Cardiovascular Center | |
Suita, Osaka, Japan, 565-8565 |
Study Chair: | Takenori Yamaguchi, MD | National Cardiovascular Center |
Study ID Numbers: | 527-0110 |
Study First Received: | September 5, 2005 |
Last Updated: | September 5, 2005 |
ClinicalTrials.gov Identifier: | NCT00147316 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
acute stroke thrombolytic therapy tissue plasminogen activator |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents Ischemia |
Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Necrosis Brain Ischemia Brain Infarction Infarction Plasminogen |
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Brain Diseases |
Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Necrosis Pathologic Processes Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction Plasminogen |