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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014342
Receipt No. R000016674
Scientific Title Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Date of disclosure of the study information 2014/07/01
Last modified on 2017/07/24

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Basic information
Public title Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Acronym Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Scientific Title Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Scientific Title:Acronym Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effect of the cholesterol-lowering effect on cardiac events
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Major adverse cardiac events
cardiovascular death
non-fatal acute coronary syndrome
non-fatal stroke
target vascular revascularization
Key secondary outcomes admission by congestive heart failure etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Distribution to rosuvastatin 5mg/day for 9 months
Interventions/Control_2 Distribution to atorvastatin 10mg/day for 9 months
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Coronary artery disease patinets treated with percutaneous coronary intervention
(2) Patients with LDL-cholesterol>100mg/dl
Key exclusion criteria (1)Patients who developed acute myocardial infarction within 30days from percutaneous coronary intervention
(2)Patinets who had been treated with percutaneous coronary intervention
(3)Patients treated with fibrate-based medicine
(4)Patients treated with hemodyalysis
(5)Patients diagnosed with familial hypercholesterolemia
(6)Patients who developed stroke within 3 months from percutaneous coronary intervention
(7)Patients having liver damage
(8)Patients having renal damage
(9)Patients having high level of serum creatine phosphokinase
(10)Patients treated with cyclosporin
(11)Pregnant patients
(12)Patients with hypothyroidism or muscular disorder
(13)Drug abuse and alcoholic patients
(14)Patients having carcinoma
(15)Patients having severe complications
(16)Patients having allergy of rosuvastatin or atorvastatin
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yokoyama Hiroaki
Organization Hirosaki University Graduate School of Medicine
Division name Cardiology
Zip code
Address Zaifu-cho 5, Hirosaki, Japan
TEL 0172-39-5057
Email hero8686@cc.hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yokoyama Hiroaki
Organization Hirosaki University Graduate School of Medicine
Division name Cardiology
Zip code
Address Zaifu-cho 5, Hirosaki, Japan
TEL 0172-39-5057
Homepage URL
Email hero8686@cc.hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 弘前大学大学院医学研究科(青森県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 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 Completed
Date of protocol fixation
2013 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 30 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016674

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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