UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014699
Receipt number 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 10:03:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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



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

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 or person

Institute

Daiichi Sankyo Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017085


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name