Unique ID issued by UMIN | UMIN000040318 |
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Receipt number | R000045996 |
Scientific Title | Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy |
Date of disclosure of the study information | 2020/05/07 |
Last modified on | 2020/05/07 13:04:10 |
Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy
Impact of PCSK9 Inhibitor on Lipid-rich Plaque
Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy
Impact of PCSK9 Inhibitor on Lipid-rich Plaque
Japan |
Ischemic Heart Disease
Cardiology |
Others
NO
To assess the effects of PCSK9i on coronary plaque components in patients with a history of CAD using near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS).
Efficacy
To compare administration of PCSK9i with statin-medication on coronary plaque components in patients with CAD using gray-scale- and NIRS- derived measurement
To compare administration of PCSK9i with statin-medication on biomarker profiles
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients who had received CAG and NIRS-IVUS for ACS or chronic coronary syndrome (CCS).
Patients were required to have been treated with stable LLTs (including no drug medication) for at least 4 weeks before enrollment into the present study and to have an LDL-C level of more than 80 mg/dl at baseline NIRS-IVUS.
(i) Patients with ST-elevated myocardial infarction
(ii) Chronic renal disease manifested by estimated glomerular filtration rate of less than 40 ml/min/1.73 m2
(iii) Any clinically significant abnormality identified at screening visit, physical examination, laboratory tests, or comorbidities, which, in the judgment of the investigator, would preclude safe completion of the study (to continue LLTs or perform a follow-up NIRS-IVUS).
50
1st name | Hitoshi |
Middle name | |
Last name | Matsuo |
Gifu Heart Center
Department of Cardiology
500-8384
4-14-4 Yabuta-minami, Gifu-city, Gifu
058-277-2277
matsuo@heart-center.or.jp
1st name | Hideaki |
Middle name | |
Last name | Ota |
Gifu Heart Center
Department of Cardiology
500-8384
4-14-4 Yabuta-minami, Gifu-city, Gifu
058-277-2277
ota@heart-center.or.jp
Gifu Heart Center
None
Self funding
Institutional Review Board, Gifu Heart Center
4-14-4 Yabuta-minami, Gifu-city, Gifu,
058-277-2277
hide-o-5217@live.jp
NO
2020 | Year | 05 | Month | 07 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 03 | Month | 20 | Day |
2018 | Year | 05 | Month | 01 | Day |
2021 | Year | 06 | Month | 30 | Day |
The enrolled patients received LLT according to the latest guideline of American Heart Association/American College of Cardiology after baseline NIRS-IVUS, and the patients were allocated to two groups, namely statin-treated and PCSK9i-administered groups.
2020 | Year | 05 | Month | 07 | Day |
2020 | Year | 05 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045996
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