UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Specific Drug Use Survey for EFIENT Tablets Prasugrel For Japanese patients with ACS in short-term clinical practice.
Title of the study (Brief title)	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	Miyuki Arai
Organization	Daiichi Sankyo Co., Ltd.
Division name	Pharmacovigilance Department
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	Shuichi Chikada
Organization	Daiichi Sankyo Co., Ltd.
Division name	Pharmacovigilance Department
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000017085