Unique ID issued by UMIN | UMIN000031990 |
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Receipt number | R000036517 |
Scientific Title | Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI) |
Date of disclosure of the study information | 2018/03/29 |
Last modified on | 2018/07/20 11:14:37 |
Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI)
EVOLUTION Trial
Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI)
EVOLUTION Trial
Japan |
stable coronary artery disease
Cardiology |
Others
NO
To investigate the effect of evolocumab on coronary microvascular function after PCI when administered to angina patients with high LDL-C levels
Efficacy
Exploratory
Index of microvascular resistance after PCI
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Evolocumab
standard of care
20 | years-old | <= |
85 | years-old | >= |
Male and Female
(1) Patients aged 20 to 85 years at the time of informed consent.
(2) Patients with stable coronary artery disease who are planned to undergo PCI.
(3) Patients with high LDL-C levels after at least 2-week treatment of high-dose statin
(4) Patients who are capable of providing written consent.
(1) Any prior use of PCSK9 inhibitor therapy.
(2) Patients with previous MI in the terriory of the target coronary artery.
(3) Patients with target vessels which are two, three, or LMT.
(4) Patients with recent MI in past 6 weeks
(5) Patients with heart failure of New York Heart Failure Association class III or IV
(6) Patients with last known left ventricular ejection fraction <30%.
(7) Patients with serious renal impairment with an eGFR <30 mL/min/1.73 m2 at screening
(8) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal (ULN) at screening
(9) Patients who are pregnant, possibly pregnant, or breast feeding.
(10) Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies).
(11) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study.
100
1st name | |
Middle name | |
Last name | Masaharu Ishihara |
Hyogo College of Medicine
Internal Medicine, Division of Coronary Artery Disease
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501 Japan
0798-45-6553
ma-ishihara@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Masanori Asakura |
Hyogo College of Medicine
Internal Medicine, Cardiovascular Division
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501 Japan
0798-45-6553
ma-asakura@hyo-med.ac.jp
Hyogo College of Medicine
Astellas Amgen(scheduled)
Profit organization
NO
2018 | Year | 03 | Month | 29 | Day |
Unpublished
Preinitiation
2018 | Year | 03 | Month | 02 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 29 | Day |
2018 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036517
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