![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000211 |
Receipt No. | R000000281 |
Scientific Title | Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS. |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2019/06/12 |
Basic information | ||
Public title | Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS. | |
Acronym | hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
|
|
Scientific Title | Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS. | |
Scientific Title:Acronym | hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
|
|
Region |
|
Condition | |||
Condition | Ischemic stroke | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study examines an effect of HMG-CoA reductase inhibitor on serum hsCRP concentration from the ischemic stroke patients |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Serum high sensitive CRP concentration |
Key secondary outcomes | Recurrent stroke |
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 | Treatment | |
Type of intervention |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 prescription of statin within previous 30 days 5) The total cholesterol level of 180-240mg/dl within previous 30 days 6) Allowed to visit outpatient department 7) Informed consent on the form filled out by the patient. |
|||
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. |
|||
Target sample size | 1200 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
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 | 082-257-5200 | ||||||
naika3@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 and Health 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 | Osaka University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Hiroshima University Hospital Center for Integrated Medical Research |
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 | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000281 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |