ISRCTN15140257进行中（未招募）Unknown
Effect of icosapent ethyl on coronary Fat Attenuation Index score in high-risk, statin treated patients with established cardiovascular disease and elevated plasma triglycerides
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult aged =18 years old
- •2. Participants will come from one of the following groups:
- •2.1. Enrolled in the ORFAN registry OR
- •2.2. Undergone CTCA with CaRi-Heart® analysis performed
- •3. CTCA performed = 2 months before screening [defined as screening]
- •4. FAI score = 75th percentile in the left anterior coronary or right coronary artery or with FAI score = 95th percentile in the circumflex coronary artery; OR CaRi-Heart® Risk >5%
- •5. Evidence of established coronary artery disease defined by the presence of at least one of the following:
- •5.1. Evidence of coronary artery plaques (evaluable, pre-randomization CTCA with quantifiable, non-calcified plaque in an unstented segment)
- •Or Coronary artery Calcium Score (CAC) > 100
- •6. Fasting or non-fasting serum triglycerides =1.7mmol/L within the last 6 months either on ORFAN baseline blood sample or blood sample taken from routine care, whichever is available and/or most recent
- •7. Stable dose of statin therapy for >30 days before randomization
- •8. Able to undergo CT imaging of the coronary arteries at 12 months follow-up
- •9. Women of childbearing potential willing to use an acceptable method(s) of birth control during the study and for 30 days after the end of treatment, including Combined hormonal contraception (oral contraceptive pills, contraceptive patch, vaginal ring), Progestogen-only contraception (oral contraceptive pills, injectable, implant, intrauterine device [IUD], hormonal intrauterine system [IUS]), Barrier methods with spermicide (condoms, diaphragm with spermicide), Intrauterine device (IUD) without hormones, and Sterilization (surgical sterilization of the participant or partner). There are no protocol-specific birth control requirements for men with partners who can become pregnant.
- •10. Willing and able to provide written informed consent to participate in the study
排除标准
- •1. Use of other omega 3 fatty acid medicines either prescription or over the counter within the previous 28 days
- •2. Known allergy or hypersensitivity to icosapent ethyl or any of its components
- •3. History of pancreatitis or uncontrolled diabetes mellitus (HbA1c > 8% or 10.1 mmol/L)
- •4. Use of PCSK9 inhibitors within the previous 90 days
- •5. Use of Bile Acid sequestrants within the previous 7 days
- •6. Serum triglycerides >5.63mmol/L
- •7. Serum calculated or directly measured LDL-C =2.6mmol/L
- •8. Current use of anticoagulant therapy
- •9. Prior history of permanent or persistent Atrial Fibrillation. Patients with a history of paroxysmal atrial fibrillation are eligible
- •10. Any condition that, in the opinion of the study investigator, would make a patient ineligible for icosapent ethyl as per the SmPC, or for CTCA
- •11. Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids)
- •12. Severe Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or 220 µmol/l).
- •13. Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 × the upper limit of normal [ULN] measured on local labs in last 6 months)
- •14. Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
- •15. Contraindication to iodinated contrast media for CTCA.
- •16. Pregnancy or unwilling to take a pregnancy test at the randomisation visit or lactating women.
研究者
相似试验
招募中
不适用
Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemiaType 2 diabetesJPRN-UMIN000031673Yokohama City University120
已完成
不适用
Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular DiseasesHeart disorderJPRN-UMIN000023423Dokkyo Medical University Nikko Medical Center40
已完成
不适用
The Effect of Epicardial fat on non culprit plaque in patients with coronary artery disease: IVUS and OCT analysisAngina PectorisJPRN-UMIN000010766Showa University Northern Yokohama Hospital.59
未知
不适用
Visceral Fat Accumulation and Coronary Artery Disease Investigation in Japasubjects in Ningen Dock, people who recieve routine medical checkups, and coronary artery disease patientsJPRN-UMIN000002273Osaka University2,200
招募中
4 期
Effects of eicosapentaenoic acid on cardiovascular events in Japanese high risk patientsCardiovascular diseaseJPRN-UMIN000007266Kanagawa Cardiovascular and Respiratory Center200