UMIN-CTR Clinical Trial

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
Email	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
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	Nippon Medical School
Address	1-1-5, Sendagi, Bunkyo, Tokyo, Japan
Tel	0338222131
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001674