Unique ID issued by UMIN | UMIN000017547 |
---|---|
Receipt number | R000020338 |
Scientific Title | Acute phase platelet reactivity in patients with acute coronary syndrome |
Date of disclosure of the study information | 2015/05/13 |
Last modified on | 2018/05/24 16:29:08 |
Acute phase platelet reactivity in patients with acute coronary syndrome
platelet reactivity in patients with acute coronary syndrome
Acute phase platelet reactivity in patients with acute coronary syndrome
platelet reactivity in patients with acute coronary syndrome
Japan |
Acute Coronary syndrome
Cardiology | Adult |
Others
NO
The aim of this study is to evaluate the acute phase platelet reactivity in patients with acute coronary syndrome to be treated with prasugrel
Efficacy
Exploratory
Others
The primary efficacy endpoint is the change of platelet reactivity unit (PRU) and inhibition rate which measured by VerifyNow P2Y12 platform assay.
PRU is measured before prasugrel start, and 30 minutes, one hour, 2hours, 4hours and 6hours after prasugrel loading dose(20mg), and Prasugrel maintenance dose(3.75mg) and clopidogrel maintenance dose (75mg)
The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and the average value of the change of PRU,
Observational
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1. Patients with ischemic heart disease who will undergo or have undergone percutaneous coronary intervention
2. Patients who are provided of the written agreement
3. Twenty to 85 years old
1. Patients with contraindications to prasugrel
2. Patients who have severe liver problem
3. Patients who have severe kidney problem
4. Weigh 45 kg or less
5. low platelet counts (less than 10*10^4)
6. Pregnant
7. Patients who are taking anticoagulants
8. Patients who are planned to administer thrombolytic agents
9. Patients scheduled for PCI or coronary artery bypass graft during this study
10. Patients who are taking ticlopidine or cilostazol
11.Cardiogenic shock
12.History of stroke or transient ischemic attack
13. Patients judged as inappropriate for trial entry
50
1st name | |
Middle name | |
Last name | Yoshio Kobayashi |
Chiba University Hospital
Department of Cardiovascular Medicine
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
043-226-2340
aapa6508@chiba-u.jp
1st name | |
Middle name | |
Last name | Shinichi Wakabayashi |
Chiba University Hospital
Department of Cardiovascular Medicine
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
043-226-2340
worldpeacewaka@yahoo.co.jp
Chiba University
Chiba Univerity, Department of Cardiovascular Medicine
Self funding
NO
2015 | Year | 05 | Month | 13 | Day |
Published
Main results already published
2014 | Year | 08 | Month | 27 | Day |
2014 | Year | 10 | Month | 24 | Day |
Prospective study
2015 | Year | 05 | Month | 13 | Day |
2018 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020338
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |