UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Title of the study (Brief 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
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	Yokoyama Hiroaki
Organization	Hirosaki University Graduate School of Medicine
Division name	Cardiology
Address	Zaifu-cho 5, Hirosaki, Japan
TEL	0172-39-5057
Email	hero8686@cc.hirosaki-u.ac.jp

Public contact
Name of contact person	Yokoyama Hiroaki
Organization	Hirosaki University Graduate School of Medicine
Division name	Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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