UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018751 |
|---|---|
| Receipt number | R000020691 |
| Scientific Title | Acute phase intra-stent tissue reduction effect of prasugrel compared with clopidogrel in patient with acute coronary syndrome |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2015/08/21 11:02:58 |
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Basic information
Public title
Acute phase intra-stent tissue reduction effect of prasugrel compared with clopidogrel in patient with acute coronary syndrome
Acronym
Acute effect of parsugrel in ACS
Scientific Title
Acute phase intra-stent tissue reduction effect of prasugrel compared with clopidogrel in patient with acute coronary syndrome
Scientific Title:Acronym
Acute effect of parsugrel in ACS
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to observe acute response of tissue inside the stent after primary PCI for ACS and to compare the effect of novel P2Y12 inhibitor, prasugrel, with clopidogrel.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary end point of the study was IST score reduction between the 2 treatment groups.
Key secondary outcomes
The secondary end points was the difference in each maximal smooth and irregular IST area reduction between the 2 treatment groups.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The patient with ACS undergoing primary PCI to curprit lesion with stent implantation.
2)The patient scheduled to be performed secondary OCT after 3days to 1month of primary PCI.
Key exclusion criteria
1. Patients who cannot give informed consent.
2. Absolute contraindications or allergy that cannot be pre-medicated to iodinated
contrast or to any of the study medications including both prasgrel and clopidgrel.
3. Contraindications to angiography.
4. If it is known, pregnant or nursing mothers.
5. If it is known, a creatinine clearance <30 mL/min.
6. Previous enrolment in this study.
7. Randomisation or planned use of other investigational drugs or devices in this trial.
8. the opinion of the investigator would result in suboptimal imaging or excessive risk
of complication from placement of an OCT catheter.
9. insufficient OCT image quality
10. stent thrombosis was developed before secondary OCT
11. cardiac arrest
12. PCI performed on the next day after PCI due to unstable hemodynamic status or chest pain
13. Curprit lesion located in (left main trunk or in )the ostial coronary artery or in a previous stent implantation(stent occulusion or stent restenosis) or in a saphenous vein graft ,in arterial bypass.
14. Stroke was developed after PCI
15. uncontrollable heart failure
16. active bleeding
17. active infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiology
Zip code
Address
7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL
078-382-5111
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Tsukiyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiology
Zip code
Address
7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL
078-382-5111
Homepage URL
yoshiro.tsukiyama0920@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Saiseikai Nakatsu Hospital
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
大阪府済生会中津病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 21 | 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
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
provisional observational study
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2015 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020691
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| Registered date | File name |
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| Registered date | File name |
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