UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010850 |
|---|---|
| Receipt number | R000012693 |
| Scientific Title | Japan registry to use of Promus element in acute coronary syndrome patients |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/12/08 17:15:01 |
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Basic information
Public title
Japan registry to use of Promus element in acute coronary syndrome patients
Acronym
J-POSEIDON registry
Scientific Title
Japan registry to use of Promus element in acute coronary syndrome patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoru Otsuji, Junya Shitte, Yoshinori Yasaka |
Organization
Higashi Takarazuka Satoh Hospital, Osaka Saiseikai Nakatsu Hospital , Hyogo Brain and Heart Center
Division name
Cardiology
Zip code
Address
Saisyoko 520, Himeji, Hyogo, Japan 6700981
TEL
079-293-3131
j.poseidon.registry@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Yasaka |
Organization
Hyogo Brain and Heart Center
Division name
Cardiology
Zip code
Address
Saisyoko 520, Himeji, Hyogo, Japan 6700981
TEL
079-293-3131
Homepage URL
j.poseidon.registry@gmail.com
Sponsor or person
Institute
Society of ACS Intervention and
Therapeutics
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012693
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
