UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011719 |
|---|---|
| Receipt number | R000013701 |
| Scientific Title | Effect of Rosuvastatin therapy on coronary fibrous-cap thickness in patients with acute coronary syndrome : Assessment by frequencey domain optical coherence tomography study |
| Date of disclosure of the study information | 2013/09/11 |
| Last modified on | 2015/06/17 21:05:31 |
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Basic information
Public title
Effect of Rosuvastatin therapy on coronary fibrous-cap thickness in patients with acute coronary syndrome : Assessment by frequencey domain optical coherence tomography study
Acronym
Effect of lipid decrease treatment on plaque composition in patients with acute coronary syndrome(ACS)
Scientific Title
Effect of Rosuvastatin therapy on coronary fibrous-cap thickness in patients with acute coronary syndrome : Assessment by frequencey domain optical coherence tomography study
Scientific Title:Acronym
Effect of lipid decrease treatment on plaque composition in patients with acute coronary syndrome(ACS)
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome patients who have thin-cap fibroatheroma in non-culprit lesion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The stabilization of the vulnerable plaque with the rosuvastatin is confirmed by using FD-OCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of coronary fibrous-cap thickness of 6 months treatment with rosuvastatin.
Key secondary outcomes
# Change of serum lipid: LDL-C change rate, TG change rate, HDL-C change rate, LDL-C/HDL-C change rate, non-HDL-C change rate
# Relation between change of coronary fibrous-cap thickness with OCT and serum lipid
# Change of coronary artery plaque CT value by MDCT
# Relation between thickness change and serum lipid of coronary artery plaque CT value by OCT
# Coronary artery plaque CT value change judged MDCT and relation to change of OCT opinion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin 2.5mg-20mg 6 months
Interventions/Control_2
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
The patients to fill the following standard, who have undergone PCI to acute coronary syndromes (ACS), who have the past of unstable angina pectoris(UAP) among hypercholesterolemia patients on standby PCI enforcement.
1) Patients with LDL-C >= 100 mg/dL(treated group) and < 140 mg/dL(untreated group)
2) Patients aged 20 years over,
outpatient, hospitalization, and sex pretermission.
3) Patient to whom existence of TCFA was confirmed by FD-OCT.
4) Patients who are able to submit written consent agreement by themselves.
5) 20-year-old or more man and woman of PCI enforcement hypercholesterolemia patient who has coronary artery disease.
Key exclusion criteria
1) Patient who needs lipid-lowering therapy other than research medicine during study period.
2)Patients with homozygous familial hypercholesterolemia,secondary hypercholesterolemia.
3) Patients with serum triglyceride > 400 mg/dL
4) Patient who has previous history of hypersensitivity for Statin.
5) Patients with hepatic function disorder (AST/ALT>= 100 IU/L, total bilirubin > 2.5mg/dL)
6) Patients with renal function disorder (serum creatinine >= 2.0mg/dL or creatinine clearance < 30mL/min/1.73m2)
7) Patients with serum CK > 500 IU/L
8) Patients receiving cyclosporine.
9) Pregnant women and women suspected of being pregnant.
10) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases.
11)Patients with history of drug-related muscular disorder.
12) Patients with drug abuse or alcoholism.
13) Patient who has received treatment with medicines other than research medicine.
Though using the medicine together other than the research medicine are enabled during this study period.The usage and the dosage are assumed to be no change during this study period.
Statin other than research medicine, fibrate, cholesterol transporter inhibitor, and cyclosporines
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Miura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minanikogushi,Ube-shi,Yamaguchi-ken 755-8505,Japan
TEL
0836-22-2248
toshiro@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Okamura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minanikogushi,Ube-shi,Yamaguchi-ken 755-8505,Japan
TEL
0836-22-2248
Homepage URL
t-okamu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine Department of Medicine and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine Department of Medicine and Clinical Science
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 20 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2015 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013701
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
