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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003265
Receipt No. 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 2011/09/28

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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
Middle name
Last name Kyoichi Mizuno
Organization Nippon Medical School
Division name Department of Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL 03-3822-2131
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Takano
Organization Nippon Medical School
Division name Department of Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL 03-3822-2131
Homepage URL
Email htakano@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
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 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
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 No longer recruiting
Date of protocol fixation
2008 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 28 Day
Last modified on
2011 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001674

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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