Dyslipidemia with a history of coronary artery disease Dyslipidemia
Conditions
Interventions
After consent is obtained, eligible subjects will be randomly assigned to receive either pemafibrate
0.2mg/day or no dose.Compare the values of various parameters 12 weeks after the start of administ
Sponsors
Tsujita Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age>=20, regardless of gender 2)History of coronary artery disease 3)150mg/dL<= fasting or occasional TG<500mg/dL within 3 months before informed consent 4)LDL-C<100mg/dL within 3 months before informed consent 5)Under receiving of statin without changing the type and the dose more than 3 months before informed consent 6)Under receiving of a single antiplatelet drug without changing the type and the dose more than 14 days at the time of Visit 0 7) Written consent for participation to this study
Exclusion criteria
Exclusion criteria: 1)Subjects to whom the study drugs are contraindicated in the package inserts 2)Subjects who developed acute coronary syndrome within the past 3 months from the day of the consent acquisition 3)serum-Cr>=1.5mg/dL 4)Under receiving of fibrates or omega 3 fatty acid preparations or equivalent supplements within 3 months before informed consent 5)Under receiving of anticoagulants within 7 days before informed consent,or with plans 6)With plans for major surgery with a blood transfusion 7)Under receiving of antiplatelet drug treatment other than aspirin, clopidogrel, and prasugrel 8)Subjects judged unsuitable to the study from staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of changes in plasma fibrinogen at 0 week (baseline) and 12 weeks after the start of administration (FAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Amount of changes in plasma fibrinogen at 0week (baseline) and 12 weeks after the start of administration (PPS) 2)Percent change in fibrinogen and change and percent change in each parameter (FAS, PPS) from baseline at 12 weeks after the start of administration Parameter:lipid, glucose metabolism, liver function,renal function, heart-related markers 3)Change and percent change from baseline in thrombosis-forming ability measured using a primary hemostatic ability measuring device (T-TAS01;Fujimori Kogyo Co., Ltd., Tokyo) 4)Change and percent change of coagulation/fibrin olysis parameters (PT-INR, APTT, D-dimer, t-PA antigen) from baseline (FAS, PPS) 5)Correlation between thrombus forming ability(delta AR-AUC, delta PL-AUC) and each parameter (FAS, PPS) 6)Correlation of change and percent change between thrombus forming ability (delta AR-AUC, delta PLAUC) and each parameter (FAS, PPS) 7)Safety: Information on diseases, etc. and adverse events(SAS) | — |
Contacts
Public ContactKenichi Tsujita
Kumamoto University Hospital
Outcome results
None listed