Unique ID issued by UMIN | UMIN000014699 |
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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 |
Specific Drug Use Survey for EFIENT Tablets
Prasugrel For Japanese patients with ACS in short-term clinical practice.
PRASFIT-Practice I
Specific Drug Use Survey for EFIENT Tablets
Prasugrel For Japanese patients with ACS in short-term clinical practice.
PRASFIT-Practice I
Japan |
ACS patients who are to undergo PCI or who have just undergone PCI
Cardiology | Intensive care medicine |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
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
Observational
Not applicable |
Not applicable |
Male and Female
ACS patients who are to undergo PCI or who have just undergone PCI.
None
500
1st name | |
Middle name | |
Last name | Miyuki Arai |
Daiichi Sankyo Co., Ltd.
Pharmacovigilance Department
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
+81-3-6225-1044
arai.miyuki.ue@daiichisankyo.co.jp
1st name | |
Middle name | |
Last name | Shuichi Chikada |
Daiichi Sankyo Co., Ltd.
Pharmacovigilance Department
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
+81-3-6225-1044
chikada.shuichi.ic@daiichisankyo.co.jp
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd.
Profit organization
JAPAN
NO
2014 | Year | 07 | Month | 30 | Day |
Unpublished
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.
Completed
2014 | Year | 05 | Month | 23 | Day |
2014 | Year | 05 | Month | 27 | Day |
2015 | Year | 01 | Month | 26 | Day |
2015 | Year | 11 | Month | 30 | Day |
2016 | Year | 02 | Month | 01 | Day |
This study was performed according to the continuous investigation system.
2014 | Year | 07 | Month | 29 | Day |
2018 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017085
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