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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018751
Receipt No. 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

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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
Email 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
Email yoshiro.tsukiyama0920@gmail.com

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020691

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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