UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016780 |
|---|---|
| Receipt number | 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 16:39:56 |
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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
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
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019472
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| Registered date | File name |
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| Registered date | File name |
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