UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Title of the study (Brief title)	Effects of Aggressive Lipid Lowering Therapy With Atorvastatin on the Fibrous cap Thickness of Thin-cap Fibroatheroma: Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Study
Region	Japan

Condition
Condition	Acute Coronary Syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is an exploratory study aiming to elucidate the mechanism underlying plaque stabilization of statin treatment using Optical Coherence Tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	For the plaques evaluated by OCT, what are the differences in plaque-stabilizing effects of atorvastatin in plaques with different characteristics (fibrous cap thickness)?
Key secondary outcomes	1. Are LDL-C and fibrous-cap thickness inversely-correlated? 2. Are plaque volume and fibrous-cap thickness inversely-correlated? 3. Does atorvastatin suppress new plaque formation?

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	10 to 20 mg pitavastatin daily started within 24 hours of PCI to maintain LDL-cho level less than 70mg/dl
Interventions/Control_2	Control
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. Patients with acute coronary syndrome (including ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction and unstable angina). 2. Patients who have at least one critical stenosis involving 75% or more of the stenosis 3. LDL-cho level between 100mg/dl and 180mg/dl 4. Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study
Key exclusion criteria	1. Patients who will undergo elective percutaneous coronary intervention, 2. Patients who received thrombolytic therapy 3. Previous statin treatment 4. Severe left ventricular dysfunction (Ejection fraction <40% by echocardiogram), 5. Uncontrolled severe diabetes mellitus (HbA1c >12.0%).
Target sample size	50

Research contact person
Name of lead principal investigator	Tohru Masuyama
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL	0798-45-6553
Email

Public contact
Name of contact person	Kenichi Fujii
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL	0798-45-6553
Homepage URL
Email	kfujii@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine Cardiovascular Division
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 05 Month 01 Day
Anticipated trial start date	2008 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2010 Year 05 Month 16 Day
Last modified on	2018 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004362