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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004608
Receipt No. R000005502
Scientific Title Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)
Date of disclosure of the study information 2010/11/23
Last modified on 2012/06/06

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Basic information
Public title Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)
Acronym ARIS study
Scientific Title Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)
Scientific Title:Acronym ARIS study
Region
Japan

Condition
Condition Hypercholesterolemia coupled with ischemic stroke
Classification by specialty
Cardiology Endocrinology and Metabolism Neurology
Vascular surgery Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of atorvastatin and rosuvastatin on lipid and inflammatory markers (high-sensitivity CRP) in ischemic stroke patients with hypercholesterolemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The percent change of LDL-C, HDL-C, TG and high-sensitivity CRP composition after 12 months
Key secondary outcomes 1) Percent change of LDL-C/HDL-C ratio
2) Percent change of non HDL-C
3) Major adverse cardiac and cerebrovascular events
4) Changes in intima-media thickness (max and mean IMT)
5) Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rosuvastatin will be administered within 7 days after ischemic stroke onset and continued for 12 months at a dosage of 5mg/day. If treatment fails to reduce the LDL-C level enough, the dosage can be increased.
Interventions/Control_2 Atorvastatin will be administered within 7 days after ischemic stroke onset and continued for 12 months at a dosage of 10mg/day. If treatment fails to reduce the LDL-C level enough, the dosage can be increased.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients within 7 days of stroke onset
2) Patients with the LDL-C level of more than 120 mg/dL
3) Patients aged 20 years or older at the time of giving consent
4) No limitations on gender or hospitalization status
5) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
Key exclusion criteria 1) Patients with Japan Coma Scale (JCS) greater than 10 (Patients who cannot take foods orally)
2) Patients who have received atorvastatin or rosuvastatin before the observation period
3) Patients with familial hypercholesterolemia or secondary hyperlipidemia
4) Patients with the fasting TG level of more than 400 mg/dL
5) Patients with hypersensitivity to HMG-CoA reductase inhibitor(statin)
6) Patients within 3 months of stroke onset
7) Patients with active liver disease (ALT or AST levels more than 100IU/L, or a total bilirubin of more than 2.5 mg/dL)
8) Patients with renal dysfunction (the serum creatinine more than 2.0 mg/dL or Ccr<30mL/min/1.73 square meter)
9) Patients with the serum creatine kinase (CK) levels greater than 500IU/L
10) Patients on treatment with cyclosporine
11) Pregnant and potential pregnancy
12) Patients with hypothyroidism, hereditary myopathy (muscular dystrophy) or family history of hereditary myopathy, and drug-induced myopathy
13) Patients with drug abuse or alcoholism
14) Patients who are ineligible for any other reason in the opinion of the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Mori
Organization Shonan Kamakura General Hospital
Division name Deaprtment of Stroke Treatment
Zip code
Address Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan
TEL 0467-46-1717
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Miyazaki
Organization Shonan Kamakura General Hospital
Division name Department of Stroke Treatment
Zip code
Address Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan
TEL 0467-46-1717
Homepage URL
Email

Sponsor
Institute Department of Stroke Treatment,Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 湘南鎌倉総合病院脳卒中診療科

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2010 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
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
2010 Year 11 Month 23 Day
Last modified on
2012 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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