UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014283 |
|---|---|
| Receipt number | 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 16:36:28 |
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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
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
ebifender@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine Shinshu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016632
