Pemafibrate and coronary plaque characteristics

JRCT ID: jRCTs051190100

Registered date:30/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute coronary syndrome (ACS)
• Date of first enrollment: 30/01/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of Pemafibrate

Outcome(s)

• Primary Outcome: The change of plaque characteristic at non-culprit lesion from baseline to 9-month follow up after the administration of Pemafibrate

Secondary Outcome

Cardicac death and major cardiovascular event related with non-culprit lesion (MI, PCI, CABG)
Change of laboratry findings
Change of quantitative coronary artery at non-culprit lesion

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. ACS (STEMI or NSTEMI/Unstable angina)
2. Presence of coronary lipid plaque (fibrous cap thickness < or = 0.2 mm, and lipid angle > or = 90 degree) more than 5 mm from the target lesion for PCI
3. TG>150mg/dl
4. Age>20yo
5. Written informed consent obtained

Exclude criteria

1. SVG or in-stent restenosis lesion
2. Previous history of PCI to the target lesion
3. Vessel with diffuse coronary artery stenosis which is scheduled for PCI
4. Insulin user
5. Cardiogenic shock
6. Allergy to the study drug (Pemafibrate)
7. Severe lever injury, liver cirrhosis, or bile duct obstruction
8. Moderate to severe renal dysfunction(SCr > or = 1.5 mg/dl)
9. Presence of bile stone
10. pregnant or lactating woman
11. Use of Cyclosporine or Rifampicin
12. Use of other fibrates, omega-3 polyunsaturated fatty acids, or nicotinic acid derivatives
13. Those who are considered as unsuitable candidate by investigators
14. Those who are psyhosis, or are difficault to participate because of psychiatric symptoms

Related Information

• Primary Sponsor: Nogi Kazutaka
• Secondary Sponsor: Saito Yoshihiko
• Source(s) of Monetary Support: Kowa Co. Ltd.
• Secondary ID(s): UMIN000034434