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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016780
Receipt No. R000019472
Scientific Title Dose-Dependent INhibitory Effect of RosuVastatin In Japanese PatienTs with Acute Myocardial InfarcTION on Serum Concentration of Matrix Metalloproteinases
Date of disclosure of the study information 2015/04/01
Last modified on 2017/08/24

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Basic information
Public title Dose-Dependent INhibitory Effect of RosuVastatin In Japanese PatienTs with Acute Myocardial InfarcTION on Serum Concentration of Matrix Metalloproteinases
Acronym INVITATION Trial
Scientific Title Dose-Dependent INhibitory Effect of RosuVastatin In Japanese PatienTs with Acute Myocardial InfarcTION on Serum Concentration of Matrix Metalloproteinases
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Koichiro Fujisue
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
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)

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 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

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
2015 Year 03 Month 11 Day
Date of IRB
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

Other
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

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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