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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014283
Receipt No. R000016632
Scientific Title Impact of switching therapy of prasugrel to clopidogrelon platlet reaction in patients with acute coronary syndrome .
Date of disclosure of the study information 2014/06/20
Last modified on 2017/06/18

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Basic information
Public title Impact of switching therapy of prasugrel to clopidogrelon platlet reaction in patients with acute coronary syndrome .
Acronym Impact of switching therapy of prasugrel to clopidogrel in patients with acute coronary syndrome .
Scientific Title Impact of switching therapy of prasugrel to clopidogrelon platlet reaction in patients with acute coronary syndrome .
Scientific Title:Acronym Impact of switching therapy of prasugrel to clopidogrel in patients with acute coronary syndrome .
Region
Japan

Condition
Condition acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to examine the efficacy and safety of switching therapy of prasugrel to clopidogrel by the cahnege of platelet reactivity assessed by Verify Now assay.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes P2Y12-reaction-units (PRU) assessed by VerifyNow assay.
Key secondary outcomes

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
Medicine
Interventions/Control_1 prasugrel and clopidogrel
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with acute coronary syndrome who underwent stent implantation
Key exclusion criteria Previous warfarin or thienopyridine use.
Recent bleeding history.
Hematological criteria.
Renal insuffiency.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichiro Ebisawa
Organization Shinshu Uniersity Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto
TEL 0263-37-3352
Email ebifender@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichiro Ebisawa
Organization Shinshu Uniersity Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto
TEL 0263-37-3352
Homepage URL
Email ebifender@yahoo.co.jp

Sponsor
Institute Department of Cardiovascular Medicine Shinshu University Hospital
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine Shinshu University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 20 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
2014 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 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
2014 Year 06 Month 16 Day
Last modified on
2017 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016632

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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