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Pemafibrate and coronary plaque characteristics

Phase 2
Recruiting
Conditions
Acute coronary syndrome (ACS)
Acute coronary syndome, Pemafibrate, lipid plaque
Registration Number
JPRN-jRCTs051190100
Lead Sponsor
ogi Kazutaka
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion 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

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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