Early TRIPLE versus dual LIPID lowering treatment in peOple with atherosclerotic cardiovascular disease and hypercholesterolemia Undergoing elecTive revascularisation

Trial details

Who runs it

Medical University Of Graz

Trial code

EU 2026-525917-29-00

Record updated

2026. július 17.

Original description

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 ODRead full original descriptionShow less

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

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

Inclusion: 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.

Exclusion: 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); Conditions that prevent people from following the study procedures; History or presence of acute coronary syndrome; History or presence of acute stroke; eGFR <30 ml/min/1,73m2; AST or ALT > 3 times upper limit or normal; Fasting triglycerides >400 mg/dl; 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; History or acute episode of gout; Known intolerance for statins, ezetimibe or bempedoic acid; Known homozygous familial hypercholesterolaemia; Known alcohol abuse (more than 15 drinks / week); Known active carcinoma (basalioma and intraepithelial neoplasia are excluded); History or presence of acute limb ischaemia; Pregnancy or intention of becoming pregnant or breastfeeding women.

EU CTIS 2026-525917-29-00