Effect of PEMAfibrate on COronary plaques and REnal function in patients with cardiovascular disease and elevated fasting triglyceride

Not Applicable

Recruiting

• Conditions: Coronary artery disease; ACS, Stable angina, SMI

• Registration Number: JPRN-jRCTs031210067
• Lead Sponsor: Yasuda Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) male and female aged 20 years or older and younger than 85 years at giving their consent
2) Patients with coronary artery disease, which meets the medical indication of percutaneous coronary intervention (PCI), or patients with suspected coronary artery disease, which meets the medical indication of coronary angiography, according to the JCS 2018 Guideline on Diagnosis of Chronic Coronary Heart Diseases, the JCS 2018 Guideline on Revascularization of Stable Coronary Artery Disease, or the JCS 2018 Guideline on Diagnosis and Treatment of Acute Coronary Syndrome, released by the Japanese Circulation Society.
3) Patients who have used statin continuously 180 days or longer before the planned day of the PCI (regardless of types, dose, or changes of statins).
4) Patients whose LDL-c under the treatment with statin became less than 100mg/dL at least once within 60 days before the planned day of the PCI.
5) Patients whose fasting triglyceride under the treatment with statin became 150mg/dL or higher and less than 500mg/dL at least once within 60 days before the planned day of the PCI.
6) Patients who provide their consent to participate in this study in a written form by themselves.

Provisionally-registered patients who meet all of the following inclusion criteria and do not fall into any of exclusion criteria are actually registered, based on the findings by the coronary angiography and coronary imaging at the time of PCI, the success or failure of the PCI, and the status of statin administration. If the provisionally-registered patients are judged to be ineligible at this time, the patients are not registered.
1) Patients in whom the PCI procedure at the culprit lesion of the coronary artery disease was succeeded.
2) Patients who have another coronary lesion which is less than 75% by AHA lesion classification at proximal or distal portion apart from the PCI-treated lesion 5mm or more, or patients who have another coronary lesion which is less than 75% by AHA lesion classification at different coronary artery branches from the PCI-treated lesion.
3) Patients who have used statin continuously 180 days or longer before the actual registration.

Exclusion Criteria

1) Patients with heart failure (class III or IV by NYHA classification)
2) Patients with poorly-controlled hypertension (systolic blood pressure is 200mmHg or higher, or diastolic blood pressure is 110mmHg or higher) regardless of antihypertensive agents administration
3) Patients with poorly-controlled diabetes mellitus (HbA1c is 9.5% or higher)
4) Patients with hepatic dysfunction (ALT or AST is 2.5 fold or more higher than the upper limit of normal)
5) Patients with hepatic cirrhosis (Child-Pugh class B or C)
6) Patients with gallstone or biliary obstruction
7) Patients with renal dysfunction (serum creatinine is 1.5mg/dL or higher) or patients who are treated by dialysis.
8) Patients who are using any fibrates, PCSK9 inhibitors, EPAs, or EPA/DHAs.
9) Patients who are breastfeeding, pregnant, or possibly pregnant.
10) Patients who are using cyclosporine or rifampicin.
11) Patients who have history of hypersensitivity against pemafibrate.
12) Patients who are participating other clinical studies.
13) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.

1) Patients who have history of PCI at the target plaque to be analyzed in this study confirmed by the intravascular ultrasonography.
2) Patients who may undergo another PCI in the same vessel as the target plaque to be analyzed in this study confirmed by the intravascular ultrasonography during the study period.
3) Patients with significant calcification confirmed by coronary angiography in the coronary artery with the target plaque to be analyzed in this study, which may make NIRS/IVUS and OCT difficult in the vessel.
4) Patients with significant bending confirmed by coronary angiography in the coronary artery with the target plaque to be analyzed in this study, which may make NIRS/IVUS and OCT difficult in the vessel.
5) Patients who are expected to be treated with coronary artery bypass graft surgery during the study period
6) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Percent change in volume of the target plaque to be analyzed in this study, which is not treated by PCI in the longitudinal 10mm segment from baseline to week 72<br>2) Change in LCBImax4mm assessed by NIRS at the target plaque to be analyzed in this study, which is not treated by PCI from baseline to week 72