UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014342 |
|---|---|
| Receipt number | R000016674 |
| Scientific Title | Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2017/07/24 16:15:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Acronym
Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Scientific Title
Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Scientific Title:Acronym
Randomized controlled trial of the lipid-lowering therapy with rosuvastatin and atorvastatin for the patients with coronary artery disease treated with percutaneous coronary intervention
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of the cholesterol-lowering effect on cardiac events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major adverse cardiac events
cardiovascular death
non-fatal acute coronary syndrome
non-fatal stroke
target vascular revascularization
Key secondary outcomes
admission by congestive heart failure etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Distribution to rosuvastatin 5mg/day for 9 months
Interventions/Control_2
Distribution to atorvastatin 10mg/day for 9 months
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) Coronary artery disease patinets treated with percutaneous coronary intervention
(2) Patients with LDL-cholesterol>100mg/dl
Key exclusion criteria
(1)Patients who developed acute myocardial infarction within 30days from percutaneous coronary intervention
(2)Patinets who had been treated with percutaneous coronary intervention
(3)Patients treated with fibrate-based medicine
(4)Patients treated with hemodyalysis
(5)Patients diagnosed with familial hypercholesterolemia
(6)Patients who developed stroke within 3 months from percutaneous coronary intervention
(7)Patients having liver damage
(8)Patients having renal damage
(9)Patients having high level of serum creatine phosphokinase
(10)Patients treated with cyclosporin
(11)Pregnant patients
(12)Patients with hypothyroidism or muscular disorder
(13)Drug abuse and alcoholic patients
(14)Patients having carcinoma
(15)Patients having severe complications
(16)Patients having allergy of rosuvastatin or atorvastatin
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yokoyama Hiroaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
Zaifu-cho 5, Hirosaki, Japan
TEL
0172-39-5057
hero8686@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yokoyama Hiroaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
Zaifu-cho 5, Hirosaki, Japan
TEL
0172-39-5057
Homepage URL
hero8686@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
弘前大学大学院医学研究科(青森県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016674
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
