2026-525917-29-00招募中4 期
Early TRIPLE versus dual LIPID lowering treatment in peOple with atherosclerotic cardiovascular disease and hypercholesterolemia Undergoing elecTive revascularisation - The randomized, controlled, open-label, parallel group TRIPLE-LIPID-OUT trial
Medical University Of Graz11 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2026年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 11
- 主要终点
- Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 weeks (V2) between the two study groups
研究概览
简要总结
The primary objective is to investigate the percentage of trial participants achieving an LDL-C <55 mg/dl on either a triple lipid lowering treatment including rosuvastatin 20 mg OD, ezetimibe 10 mg OD and bempedoic acid 180 mg OD compared to a dual therapy of rosuvastatin 20 mg OD and ezetimibe 10 mg OD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years, both inclusive
- •Informed consent has to be given in written form
- •Atherosclerotic cardiovascular disease with an indication for coronary or peripheral artery revascularisation
- •LDL-C at Screening (Visit S – only required, if trial participant is on no or other statin treatment than rosuvastatin 20 mg OD) in the following range depending on lipid lowering treatment: - LDL-C >130 mg/dl and <170 mg/dl when on no lipid lowering treatment - LDL-C >70 mg/dl and <110 mg/dl when pretreated with either simvastatin 40 mg, atorvastatin 10-20 mg or rosuvastatin 10 mg monotherapy - LDL-C >55 mg/dl and <100 mg/dl when pretreated with either atorvastatin 40 mg or rosuvastatin 20 mg - LDL-C >55 mg/dl and <85 mg/dl when pretreated with either atorvastatin 80 mg OD or rosuvastatin 40 mg
- •LDL-C at V1 >55 mg/dl and <100 mg/dl while on rosuvastatin 20 mg OD
- •Tolerability of statin treatment during the run-in phase or if participants enter the study directly at Visit 1, tolerability of a stable rosuvastatin 20 mg OD treatment over 6 weeks prior to Visit 1.
排除标准
- •Treatment with ezetimibe, bempedoic acid or an PCSK9 inhibitor within the last 8 weeks or inclisiran within the last 12 months
- •Females of childbearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectomised partner; or medical history of hysterectomy)
- •eGFR <30 ml/min/1,73m2
- •AST or ALT > 3 times upper limit or normal
- •History or acute episode of gout
- •Known intolerance for statins, ezetimibe or bempedoic acid
- •Known homozygous familial hypercholesterolaemia
- •Fasting triglycerides >400 mg/dl
- •Known alcohol abuse (more than 15 drinks / week)
- •Trial participant has participated in another study of an investigational medication or an investigational medical device (except for observational studies using continuous glucose monitoring devices) within the last 30 days or is currently participating in these studies.
- •Conditions that prevent people from following the study procedures
- •Known active carcinoma (basalioma and intraepithelial neoplasia are excluded)
- •History or presence of acute coronary syndrome
- •History or presence of acute limb ischaemia
- •History or presence of acute stroke
- •Pregnancy or intention of becoming pregnant or breastfeeding women
研究组 & 干预措施
Nustendi 180 mg/10 mg film-coated tablets
Test
干预措施: Nustendi 180 mg/10 mg film-coated tablets (Drug)
Ezegelan 10 mg-Tabletten
Comparator
干预措施: Ezegelan 10 mg-Tabletten (Drug)
Rosuvalan 20 mg-Filmtabletten
Auxiliary
干预措施: Rosuvalan 20 mg-Filmtabletten (Drug)
结局指标
主要结局
Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 weeks (V2) between the two study groups
Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 weeks (V2) between the two study groups
次要结局
- Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 months follow up between the two study groups
- Difference in mean change of LDL-C levels between the two study groups from V1 to V2
- Difference in mean change of LDL-C levels between the two study groups from V1 to 12 months
- Difference in mean change of Apo-B100 levels between the two study groups from V1 to V2
- Difference in mean change of Apo-B100 levels between the two study groups from V1 to 12months
- Difference in mean change of Apo-A1 levels between the two study groups from V1 to V2
- Difference in mean change of Apo-A1 levels between the two study groups from V1 to 12 months
- Difference in mean change of apolipoprotein (a) levels between the two study groups from V1 to V2
- Difference in mean change of apolipoprotein (a) levels between the two study groups from V1to 12 months
- Difference in mean change of hs-CRP levels between the two study groups from V1 to V2
- Difference in mean change of hs-CRP levels between the two study groups from V1 to 12 months
- Difference in number of severe adverse events (SAEs) between the two groups from V1 over 12 months
- Difference in the Depression Score (HADS-D) between the two groups from V1 to V2
- Difference in the Depression Score (HADS-D) between the two groups from V1 to 12 months
- Difference in the psychological flexibility between the two groups from V1 to 12 months
- Difference in the number of adverse events between the two groups from V1 to V2
- Difference in the number of adverse events between the two groups from V1 to 12 months
- Difference in the psychological flexibility between the two groups from V1 to V2
研究者
Prof. Harald Sourij
Scientific
Medical University Of Graz
研究点 (11)
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