UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan registry to use of Promus element in acute coronary syndrome patients
Title of the study (Brief title)	J-POSEIDON registry
Region	Japan

Condition
Condition	Acute Coronary Syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and clinical outcomes with a platinum chromium everolimus-eluting stent(PROMUS) in acute coronary syndrome patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Major adverse cardiac event including cardiac death, myocardial infarction, and target lesion revascularization at 12 mont
Key secondary outcomes	TLR at 9 month/24 month TVR at 9 month/24month MI at 9 month/24 month Death at 9 month/24 month MACE at 9 month/24 month Stent thrombosis (acute, sub-acute, late, and very late) defined by Academic Research Consortium (ARC) at 9 month/ 24 month

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Define ACS (Acute coronary syndrome) as UA (unstable angina), NSTEMI (Non-ST Elevation Myocardial Infarction) and STEMI (ST Elevation Myocardial Infarction). AMI have an onset within 24 hours and meet the criteria "Universal Definition of Myocardial Infarction" defined by ESC/ACCF/AHA/WHF task force. A)Having a diagnosis of any ACS symptom B)De-novo lesion in a target vessel C)Indication for PCI D)PROMUS stent should be used with on-label use or physician assesses PROMUS stent is an appropriate device for the patient. E)Should be deployed PROMUS stent.
Key exclusion criteria	F)Enrolled in another study (excluding PMS) or receiving any treatment affected the registry. G)Pregnant or possibility of pregnancy in the registry period. H)Known hypersensitivity reaction to everolimus, polymer, metal I)Known hypersensitivity reaction to antiplatelet J)Improper functioning of the liver K)Kidney malfunction(>=3.0mg/dl serum creatinine level) or dialysis treatment. L)Active cancer M)Lesion in saphenous vein graft N)cardiogenic shock by clinical assessment
Target sample size	500

Research contact person
Name of lead principal investigator	Satoru Otsuji, Junya Shitte, Yoshinori Yasaka
Organization	Higashi Takarazuka Satoh Hospital, Osaka Saiseikai Nakatsu Hospital , Hyogo Brain and Heart Center
Division name	Cardiology
Address	Saisyoko 520, Himeji, Hyogo, Japan 6700981
TEL	079-293-3131
Email	j.poseidon.registry@gmail.com

Public contact
Name of contact person	Yoshinori Yasaka
Organization	Hyogo Brain and Heart Center
Division name	Cardiology
Address	Saisyoko 520, Himeji, Hyogo, Japan 6700981
TEL	079-293-3131
Homepage URL
Email	j.poseidon.registry@gmail.com

Sponsor
Institute	Society of ACS Intervention and Therapeutics
Institute
Department

Funding Source
Organization	Society of ACS Intervention and Therapeutics
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東宝塚さとう病院（兵庫県） 大阪府済生会中津病院（大阪府） 兵庫県立姫路循環器病センター（兵庫県） その他募集中

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective, multi-center

Management information
Registered date	2013 Year 05 Month 31 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012693