Unique ID issued by UMIN | UMIN000018003 |
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Receipt number | 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 09:32:32 |
Special Drug Use Surveillance of EFIENT Tablet
- Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -
PRASFIT-Practice II
Special Drug Use Surveillance of EFIENT Tablet
- Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -
PRASFIT-Practice II
Japan |
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.
Cardiology | Intensive care medicine |
Others
NO
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.
Safety,Efficacy
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
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.
None
4000
1st name | |
Middle name | |
Last name | SEIJI KOGURE |
Daiichi Sankyo Co., Ltd.
Post Marketing Study Department
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
+81-3-6225-1044
kogure.seiji.ia@daiichisankyo.co.jp
1st name | |
Middle name | |
Last name | HIROHIDE OUCHI |
Daiichi Sankyo Co., Ltd.
Post Marketing Study Department
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
+81-3-6225-1044
ouchi.hirohide.bm@daiichisankyo.co.jp
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd.
Profit organization
JAPAN
NO
2015 | Year | 06 | Month | 23 | Day |
Partially published
Completed
2015 | Year | 02 | Month | 20 | Day |
2015 | Year | 06 | Month | 01 | Day |
2018 | Year | 05 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 09 | Month | 30 | Day |
This study is performed according to the continuous prospective surveillance method.
2015 | Year | 06 | Month | 22 | Day |
2018 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020865
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