UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-Dependent INhibitory Effect of RosuVastatin In Japanese PatienTs with Acute Myocardial InfarcTION on Serum Concentration of Matrix Metalloproteinases
Title of the study (Brief title)	INVITATION Trial
Region	Japan

Condition
Condition	Hypercholesterolemic patients with AMI
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the potential protective effects of treatment with appropriate or low dose rosuvastatin on serum levels of inflammatory markers in patients with with acute myocardial infarction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The percent change of MMPs at 24 weeks after administration
Key secondary outcomes	1. The change and the changes rate in LDL-C, HDL-C, TG, LDL-C/HDL-C ratio at 1day, 4weeks, and 24 weeks after administration. 2. The change and the changes rate of inflammatory markers and cardiac markers at 1day, 4weeks, and 24 weeks after administration. 3. The change and the changes rate of inflammatory markers in the aortic root and the coronary sinus at 24 weeks after administration. 4. The change of the plaque volume and stabilization at 24 weeks after administration. 5. Correlation between the lipid parameters, inflammatory markers, and other parameters. 6. Achievement rates of lipid parameters according to guidelines. 7. Incidence of cerebro-cardiovascular events. 8. Incidence and types of adverse events.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rosuvastatin 10mg/day (n=60) (Starting dose: 5mg/day)
Interventions/Control_2	Rosuvastatin 2.5mg/day (n=60)
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	Patients meeting the following inclusion criteria will be included in the study: 1) Successful PCI for AMI 2) Hypercholesterolmia (LDL-C > 100mg/dL) 3) Giving voluntary written consent to participate in the study 4) 20 years old or older
Key exclusion criteria	Patients meeting the following criteria will be excluded from the study: 1) Administered statin within three month at the registration 2) Severe hypertension (SBP>=180 mmHg or DBP>=110 mmHg) 3) Familial hypercholesterolemia 4) Serum triglyceride level>=400 mg/dL 5) Prior onset of cardiovascular or cerebrovascular disease within 6 months before registration of this study 6) Hypersensitivity to statins 7) History of drug-induced myopathy 8) Active liver disease or elevated liver enzymes (ALT or AST > 3 times upper limit of normal [ULN], or bilirubin > 2 times ULN) 9) Nephrotic syndrome or renal dysfunction (creatinine clearance <30 mL/min/1.73 m2 or serum creatinine >2.0 mg/dL) 10) Administered cyclosporin 11) Serious concurrent disease such as malignancy, or patients with severely limited lifespan 12) Pregnant 13) Judged by the investigators to be ineligible for participation in the study for any other reason
Target sample size	120

Research contact person
Name of lead principal investigator	Kenichi Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Email	tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person	Koichiro Fujisue
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	fujisues@kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Graduate School of Medical Sciences, Kumamoto University
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	熊本大学大学院生命科学研究部循環器内科学

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 03 Month 11 Day
Anticipated trial start date	2015 Year 04 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	2015 Year 03 Month 11 Day
Last modified on	2017 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019472