PEMA-TAS study

JRCT ID: jRCTs071210130

Registered date:07/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dyslipidemia with a history of coronary artery disease
• Date of first enrollment: 18/04/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 administration with the values at 0 week (baseline)

Outcome(s)

• Primary Outcome: Amount of changes in plasma fibrinogen at 0 week (baseline) and 12 weeks after the start of administration (FAS)

Secondary Outcome

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)

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tsujita Kenichi
• Source(s) of Monetary Support: Kowa Company, Ltd.