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Recruitment status Completed
Unique ID issued by UMIN UMIN000014699
Receipt No. R000017085
Scientific Title Specific Drug Use Survey for EFIENT Tablets Prasugrel For Japanese patients with ACS in short-term clinical practice.
Date of disclosure of the study information 2014/07/30
Last modified on 2018/12/25

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Basic information
Public title Specific Drug Use Survey for EFIENT Tablets
Prasugrel For Japanese patients with ACS in short-term clinical practice.
Acronym PRASFIT-Practice I
Scientific Title Specific Drug Use Survey for EFIENT Tablets
Prasugrel For Japanese patients with ACS in short-term clinical practice.
Scientific Title:Acronym PRASFIT-Practice I
Region
Japan

Condition
Condition ACS patients who are to undergo PCI or who have just undergone PCI
Classification by specialty
Cardiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To obtain the information of EFIENT below in early 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 ACS who were administered EFIENT and require PCI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ACS patients who are to undergo PCI or who have just undergone PCI.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyuki Arai
Organization Daiichi Sankyo Co., Ltd.
Division name Pharmacovigilance Department
Zip code
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Email arai.miyuki.ue@daiichisankyo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Chikada
Organization Daiichi Sankyo Co., Ltd.
Division name Pharmacovigilance Department
Zip code
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Homepage URL
Email chikada.shuichi.ic@daiichisankyo.co.jp

Sponsor
Institute Daiichi Sankyo Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2014 Year 07 Month 30 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
Case report forms were collected from 749 patients, 732 of whom were eligible for the safety and efficacy analysis sets. Approximately 95% of patients had a prasugrel loading/maintenance dose of 20 mg/ 3.75 mg/day. The incidences of ADRs and bleeding AEs were 8.6 and 6.4%, respectively. Twelve patients experienced major bleeding AEs; approximately 60% (seven patients) of which were gastrointestinal disorders.
The incidence of MACE was 1.9% during prasugrel treatment, and 3.1% at the end of the study period. 
This short-term study indicated that prasugrel treatment at loading/maintenance doses of 20 mg/3.75 mg/day was safe and effective in Japanese ACS patients in an acute setting.
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
2014 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 27 Day
Last follow-up date
2015 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 02 Month 01 Day

Other
Other related information This study was performed according to the continuous investigation system.

Management information
Registered date
2014 Year 07 Month 29 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=R000017085


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