Unique ID issued by UMIN | UMIN000019164 |
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Receipt number | R000022033 |
Scientific Title | Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial |
Date of disclosure of the study information | 2015/09/30 |
Last modified on | 2018/10/08 20:06:54 |
Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial
Efficacy and Safety of Low Dose Prasugrel
Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial
Efficacy and Safety of Low Dose Prasugrel
Japan |
Acute Coronary Syndrome
Cardiology |
Others
NO
We aimed to assess the efficacy and safety of maintainance of low dose prasugrel (2.5mg/day) in Japanese acute coronary syndrome patients, especially with bleeding tendency.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
MACCE(major adverse cardiovascular and cerebral event) until coronray angiography examination at eight months after index procedure: all-cause death, cardiac death, non-fatal myocardial infarction, non-fatal cerebrovascular events, any revascularization, target lesion revascularization, stent thrombosis
in-hospital and out-hospital bleeding (until coronray angiography examination at eight months after index procedure), major bleeding not related to coronary artery bypass graft (BARC classification type 3 or greater), minor bleeding (BARC classification type 2 or less), cessation of antiplatelet drug according to bleeding events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
In patients after percutaneous coronary intervention with low body weight (body weight 50 kg or under), older age (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under), the low-dose prasugrel (2.5 mg/day) is maintained for eight months.
20 | years-old | <= |
Not applicable |
Male and Female
(1) adult patients receiving percutaneous coronary intervention with acute coronary syndrome
(2) patients with low body weight (body weight 50 kg or under), elderly (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under)
(1) bleeding patients (hemophilia, cerebral bleeding, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage)
(2) hypersensitive patients for prasugrel in past times
(Relative exclusion criteria)
(1) patients with cerebral bleeding or critical bleeding (BARC classification 3 or greater)
(2) patients with past history of cerebral infarction or transient ischemic attack
(3) patients with anticoagulant therapy or scheduled for anticoagulant therapy
(4) patients with thienopyridine therapy already
250
1st name | |
Middle name | |
Last name | Kazushige Kadota |
Kurashiki Central Hospital
Department of Cardiology
1-1-1 Miwa, Kurashiki, Okayama, Japan
086-422-0210
k-kadota@lapis.plala.or.jp
1st name | |
Middle name | |
Last name | Masanobu Ohya |
Kurashiki Central Hospital
Department of Cardiology
1-1-1 Miwa, Kurashiki, Okayama, Japan
086-422-0210
mo13590@kchnet.or.jp
Kurashiki Central Hospital
None
Other
None
None
NO
倉敷中央病院(岡山県)
2015 | Year | 09 | Month | 30 | Day |
Published
Completed
2014 | Year | 08 | Month | 26 | Day |
2014 | Year | 08 | Month | 28 | Day |
2015 | Year | 09 | Month | 30 | Day |
2018 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022033
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