UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003265 |
|---|---|
| Receipt number | R000001674 |
| Scientific Title | Prevention of myocardial injury with rosuvastatin during coronary intervention study |
| Date of disclosure of the study information | 2010/02/28 |
| Last modified on | 2021/09/07 11:32:12 |
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Basic information
Public title
Prevention of myocardial injury with rosuvastatin during coronary intervention study
Acronym
PRIMITIVE study
Scientific Title
Prevention of myocardial injury with rosuvastatin during coronary intervention study
Scientific Title:Acronym
PRIMITIVE study
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Clarify the efficacy of high dose of rosuvastatin for suppression of myocardial injury during PCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
a) PCI related cardiac complication
b) elevation of the following cardiac markers
1) troponin T
2) N-terminal pro brain natriuretic peptide
3) CPK, CPK-MB
C) EKG change after PCI
D) no reflow or slow flow after PCI
Key secondary outcomes
a) any adverse events related to rosuvastatin
b) no reflow or slow reflow during PCI
c) PCI related non-cardiac complication
d) IVUS findings before PCI
e) Cardiac events or death after 3-year follow-up period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration: from 5 - 10 days before PCI to the day of PCI
Drug: rosuvastatin 2.5 mg
Method: oral administration once a day
Interventions/Control_2
Duration: from 5 - 10 days before PCI to the day of PCI
Drug: rosuvastatin 10 mg
Method: oral administration once a day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with coronary aretery disease undergoing PCI
2. dyslipidemia (T-CHO=>220 mg/dl, TG=>150 mg/dl, HDL-CHO<40 mg/dl, or LDL-CHO=>100mg/dl, or already treated with statin)
3. Patients who agree to participate in this study.
Key exclusion criteria
1. Patients with severe renal disease (sCR=>3.0, urine protein +++ urine OB +++) or liver disease (AST>100IU/l, ALT>100IU/l, T-bil>3.0mg/dl, PT<60%, albumin<2.8g/dl)
2. ACS patients who need to receive emergency revascularization
3. Patients with no-PCI indication lesion such as LMT
4. in-stent or para-stent restenosis
5. Patients who cannot take statin
6. malignancy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kyoichi |
| Middle name | |
| Last name | Mizuno |
Organization
Nippon Medical School
Division name
Department of Medicine
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL
0338222131
htakano@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Takano |
Organization
nippon Medical School
Division name
Department of Medicine
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL
0338222131
Homepage URL
htakano@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Department of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
Tel
0338222131
htakano@nms.ac.jp
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
日本医科大学付属病院（東京都）
日本医科大学千葉北総病院（千葉県）
日本医科大学多摩永山病院（東京都）
日本医科大学武蔵小杉病院（神奈川県）
博慈会記念総合病院（東京都）
国立医療センター静岡病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/23507709/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/23507709/
Number of participants that the trial has enrolled
232
Results
The incidence of periprocedural MI did not significantly differ between the high and low-dose groups (8.7% vs 18.7%, p = 0.052). In patients who were not taking statins at the time of enrollment, high-dose rosuvastatin significantly suppressed periprocedural MI compared with the low dose. The difference was not significant in patients who were already taking statins .
Results date posted
| 2021 | Year | 09 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2013 | Year | 05 | Month | 16 | Day |
Baseline Characteristics
CAD patients undergoing PCI
Participant flow
Prospective
Adverse events
None
Outcome measures
Preprocedural myocardial injury
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2008 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001674
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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