UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021053 |
|---|---|
| Receipt number | R000024234 |
| Scientific Title | Multicenter Registry of early and Late Clinical Outcomes to Everolimus-eluting Cobalt-chromium Stent In patients with ST-elevation Acute Myocardial Infarction |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2016/02/16 16:32:14 |
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Basic information
Public title
Multicenter Registry of early and Late Clinical Outcomes to Everolimus-eluting Cobalt-chromium Stent In patients with ST-elevation Acute Myocardial Infarction
Acronym
XIENCE STEMI Registry
Scientific Title
Multicenter Registry of early and Late Clinical Outcomes to Everolimus-eluting Cobalt-chromium Stent In patients with ST-elevation Acute Myocardial Infarction
Scientific Title:Acronym
XIENCE STEMI Registry
Region
| Japan |
Condition
Condition
ST-elevation Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES.
Also, OCT sub-analysis will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Target vessel failure (TVF) at 12 months after CoCr-EES implantation.
TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) and TLR associated with the target vessel.
Key secondary outcomes
MI (QMI and Non-QMI) at 9 months and 36months
Any TLR at 9 months and 36months
Any TVR at 9 months and 36months
Death (All-cause death and Cardiac Death) at 9 months and 36months
MACE (Cardiac death, MI and TLR) at 9 months and 36months
Definite or Probable stent thrombosis defined by Academic research consortium (ARC)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cobalt Chromium Everolimus-eluting Stent System
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
1)Patients with STEMI who are able to undergo CoCr-EES implantation.
2)Patients with no history of PCI in the target vessel
3)Patients who are 20 or older at the time of informed consent
4)Patients who provided written informed consent by himself/herself
5)Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
6)Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
7)Patients who meet all the following vascular inclusion criteria
i.Patients with target lesion in native coronary artery
ii.Patients with visual maximum vessel diameter of the target stent site in target lesion
8)Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
9)Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.
Key exclusion criteria
1)Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
2)Patients presenting with cardiogenic shock
3)Patients for whom 9-month, 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
4)Patients with responsible lesion in left main trunk
5)Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
6)Patients on hemodialysis
7)Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel
(This may not apply if safety of ticlopidine is confirmed as an alternative drug.)
8)Patients who are below the age of 20 9)Women who were positive in pregnancy test or wish to become pregnant during study duration
10)Patients who newly developed AMI attributable to the prior stented site
11)Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
12)Patients diagnosed with hepatic insufficiency
13)Patients with target lesion in saphenous vein graft
14)Patients with active malignant tumor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Otsuji, Yoshinori Yasaka |
Organization
Higashi Takarazuka Sato Hospital,Hyogo Brain and Heart Center
Division name
Cardiology
Zip code
Address
Saisyoko 520, Himeji, Hyogo, Japan 6700981
TEL
079-293-3131
yoshiysk@yahoo.co.jp
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
yoshiysk@yahoo.co.jp
Sponsor or person
Institute
Nonprofit Organization Nakanihon PCI society
Institute
Department
Personal name
Funding Source
Organization
Nonprofit Organization Nakanihon PCI society
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024234
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