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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018003
Receipt No. R000020865
Scientific Title Special Drug Use Surveillance of EFIENT Tablet - Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -
Date of disclosure of the study information 2015/06/23
Last modified on 2018/12/25

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Basic information
Public title Special Drug Use Surveillance of EFIENT Tablet
- Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -
Acronym PRASFIT-Practice II
Scientific Title Special Drug Use Surveillance of EFIENT Tablet
- Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -
Scientific Title:Acronym PRASFIT-Practice II
Region
Japan

Condition
Condition Patients with any of the ischemic heart diseases specified below that require PCI:
Acute coronary syndrome (unstable angina pectoris, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction), stable angina pectoris, old myocardial infarction.
Classification by specialty
Cardiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To obtain the information of EFIENT in long-term treatment below in post-marketing phase.
To evaluate below in relation to EFIENT treatment in clinical practice
- incidence of unknown adverse drug reactions
- frequency of adverse drug reactions
- overall safety and efficacy
in patients with any of the ischemic heart diseases, who were administered EFIENT and require PCI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Safety
1) Frequency of adverse drug reactions
2) Frequency of severe adverse events
3) Frequency of bleeding events
Efficacy
- Frequency of cardiovascular events
Special population
- Safety and efficacy in patients with hepatic disease, renal disease, and elderly
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with any of the ischemic heart diseases specified below that require PCI :
Acute coronary syndrome (unstable angina pectoris, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction), stable angina pectoris, old myocardial infarction.
Key exclusion criteria None
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SEIJI KOGURE
Organization Daiichi Sankyo Co., Ltd.
Division name Post Marketing Study Department
Zip code
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Email kogure.seiji.ia@daiichisankyo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIROHIDE OUCHI
Organization Daiichi Sankyo Co., Ltd.
Division name Post Marketing Study Department
Zip code
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Homepage URL
Email ouchi.hirohide.bm@daiichisankyo.co.jp

Sponsor
Institute Daiichi Sankyo Co., Ltd.
Institute
Department

Funding Source
Organization Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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
2015 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information This study is performed according to the continuous prospective surveillance method.

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020865

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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