PEMA-TAS study

Not Applicable

Recruiting

• Conditions: Dyslipidemia; Dyslipidemia with a history of coronary artery disease

• Registration Number: JPRN-jRCTs071210130
• Lead Sponsor: Tsujita Kenichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of changes in plasma fibrinogen at 0 week (baseline) and 12 weeks after the start of administration (FAS)