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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000207 |
Receipt No. | R000000277 |
Scientific Title | Secondary prevention of HMG-CoA reductase inhibitor against stroke |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2019/06/12 |
Basic information | ||
Public title | Secondary prevention of HMG-CoA reductase inhibitor against stroke | |
Acronym | Japan Statin Treatment Against Reccurent Stroke (J-STARS) | |
Scientific Title | Secondary prevention of HMG-CoA reductase inhibitor against stroke | |
Scientific Title:Acronym | Japan Statin Treatment Against Reccurent Stroke (J-STARS) | |
Region |
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Condition | |||
Condition | Ischemic stroke | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Although it is unclear if hyperlipidemia is a risk factor of stroke or not, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase can decrease the incidence of stroke in the patients with ischemic heart disease. The neuroprotective mechanism beyond cholesterol-lowering effects could be expected to attenuate cerebrovascular inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents the ischemic stroke patients from recurrent stroke safe and sound. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | cerebrovascular events |
Key secondary outcomes | Events of ischemic stroke (subtype analysis according to the TOAST classification) or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of vascular events, death of all causes, admission to the hospital, activity of daily life, modified Rankin score, dementia and cognitive impairment, death of all causes. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Patients will be randomized into the group receiving pravastatin or that having no statin. Intervention consists of pravastain treatment (10mg/day), that will start within 1 month of entry and continue until the end of study or the endpoints. | |
Interventions/Control_2 | Non-administration group of pravastatin (control group) | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
2) 45-80 years old 3) Patients diagnosed as hyperlipidemia 4) No taking of HMG-CoA reductase inhibitor, any statin, within previous 30 days. 5) The total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days. 6)Able to visit outpatient department 7) Informed consent on the form filled out by the patient. |
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Key exclusion criteria | 1) Ischemic stroke of other determined causea according to the TOAST classification
2) Ischemic heart disease necessary to require statin 3) Hemorrhagic disorders 4) Platelet count less than 100,000/ul within 3 months before study starts 5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 100IU/L within 3 months prior to start of study 6) Serum creatinine more than 2.0mg/dl within 3 months prior to study 7) Any scheduled operations 8) The presence of malignant disorder 9) The patients participated in another clinical trial 10) The patient considered being unsuitable for the participation to the study by the medical doctor's judgment |
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Target sample size | 3000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hiroshima University Graduate School of Biomedical and Health Sciences | ||||||
Division name | Department of Clinical Neuroscience and Therapeutics | ||||||
Zip code | 734-8551 | ||||||
Address | 1-2-3 kasumi, Minami-ku, Hiroshima | ||||||
TEL | 082-257-5200 | ||||||
naika3@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hiroshima University Graduate School of Biomedical and Health Sciences | ||||||
Division name | Department of Clinical Neuroscience and Therapeutics | ||||||
Zip code | 734-8551 | ||||||
Address | 1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan | ||||||
TEL | 082-257-5201 | ||||||
Homepage URL | http://jstars.umin.ne.jp | ||||||
naika3@hiroshima-u.ac.jp |
Sponsor | |
Institute | Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical Sciences |
Institute | |
Department |
Funding Source | |
Organization | The Japanese Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Hiroshima University Hospital Center for Integrated Medical Reserch |
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima |
Tel | 082-257-1752 |
protocol@cimr.hiroshima-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.sciencedirect.com/science/article/pii/S2352396415301006 |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000277 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |