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| Sponsor: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
|---|---|
| Collaborators: |
Foundation for Biomedical Research and Innovation Neurology, Tokyo Women's Medical University, School of Medicine Kobe City General Hospital Tohoku University CVC and CR Institute, National Hospital Org. Kyushu Medical Center Department of Neurology, Saiseikai Central Hospital Cerebrovascular Division, National Cardiovascular Center |
| Information provided by: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
| ClinicalTrials.gov Identifier: | NCT00333164 |
Purpose
Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Disorders |
Drug: Asprin, Cilostazol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis (CATHARSIS) |
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Intracraial arterial stenosis (IAS) is more common in Asia, including Japanese, than in Cocasian. Also, stroke recurrence rate is high in patients with such lesions, despite medical treatment. Accoding to the result of WASID (N Engl J Med 2005;352:1305-16), warfarin is not recommended because of the concern of safety (higher risk of intracranial hemorrhage and death when compared with aspirin), wheras the efficacy of aspirin is not enough in symptomatic IAS patients. Under these conditions, we planned to conduct a nationwide multi-center, open labelled, randomized controlled trial to compare the effect of aspirin plus cilostazol (phosphodiestrase type 3 inhibitor) and aspirin alone on the progression of IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset. Patients are randomly allocated to either of two groups. Aspirin 100mg/day plus cilostazol 200 mg/day is given to the 100 patients in one group, and aspirin 100 mg/day alone is given to 100 patients in another group.
Follow-up period is at least two years. The primary endpoint is progression of IAS on MRA at two years after randomization. The secondary endpoints are cardiovascular events (ischemic stroke, myocardial infarct, and other vascular events), death, serious adverse events, new silent brain infarcts, and activity of daily life. The purpose of this study is to establish the best medical treatment in symptomatic IAS patients. This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion (PTA and/or stenting) in these patients.
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shinichiro Uchiyama, Phd. Prof. | +81-3-3353-8111 ext 39232 | suchiyam@nij.twmu.ac.jp |
| Contact: Yumi Kimura, M.D. | +81-3-3353-8111 ext 39232 | kimura@nij.twmu.ac.jp |
| Japan, Tokyo | |
| Tokyo Women's Medical University School of Medicine | Recruiting |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Contact: Shinichiro Uchiyama, M.D., Prof. 81-3-3353-8111 ext 39232 suchiyam@nij.twmu.ac.jp | |
| Contact: Yumi Kimura, M.D. 81-3-3353-8111 ext 39232 kimura@nij.twmu.ac.jp | |
| Principal Investigator: | Shinichiro Uchiyama, M.D. PhD | Department of Neurology, Tokyo Women's Medical University School of Medicine |
| Principal Investigator: | Nobuyuki Sakai, M.D. PhD | Kobe City General Hospital |
More Information
| Study ID Numbers: | UHA STROKE04-01 |
| Study First Received: | June 1, 2006 |
| Last Updated: | March 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00333164 History of Changes |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
|
intracranial arteriosclerosis cilostazol Platelete aggrigation inhibitors dual antiplatelet therapy Drug therapy, combination Clinical trials |
|
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Brain Diseases Cerebrovascular Disorders Neuroprotective Agents Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases Cilostazol Nervous System Diseases |
Vascular Diseases Anti-Asthmatic Agents Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |