Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Not Applicable

Not yet recruiting

• Conditions: ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; LDL-cholesterol
• Interventions: Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

• Registration Number: NCT05587621
• Lead Sponsor: Jena University Hospital

Brief Summary

Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).

Detailed Description

Patients admitted to the Jena University Hospital (UKS) and 9 other University hospitals in Germany with an ST-elevation or Non-ST-elevation myocardial infarction (STEMI) will be randomized to standard care or a software-based tool (CLIMEDO GmbH) to monitor low-density cholesterol (LDL-C) levels and close follow-ups to achieve ESC/EAS-guideline recommended LDL-C goals.

In this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (CLIMEDO GmbH) is superior to standard care in terms of LDL-C target attainment at 6 months and adherence over a time period of 12 months.

In the software group LDL-C levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. In the standard care group patients' LDL-C levels will be determined on admission after 6, 12 and 24 months. The primary endpoint is LDL-C target attainment at 6 months in both groups.

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Status Verified: 2023-09
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Start: 2024-04-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients with ST- and Non-ST-elevation myocardial infarctions

Exclusion Criteria

• patient without informed concent
• patients in cardiogenic shock
• patients with contraindication to lipid-lowering therapy
• patients on lipid-lowering medications on admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cloud-based software	statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran	cloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (\< 55mg/dl/1.4 mol/L)
Standard Care	statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran	Patients will be treated by general practitioners (GPs) after hospital discharge. The discharge letter will recommend ESC/EAS dyslipidemia LDL-cholesterol targets (\< 55mg/dl/1.4 mol/L)

Primary Outcome Measures

Name	Time	Method
LDL-C	6 months	LDL-C target attainment (ESC/EAS dyslipidemia guidelines)

Secondary Outcome Measures

Name	Time	Method
side-effects of lipid lowering therapy	6 months	muscle pain, hair loss, dizziness, joint pain, depression
adherence to LLT	12 months	regular LLT

Trial Locations

Locations (10)

University Hospital Jena; 🇩🇪 Jena, Thuringia, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Universitätsklinikum Halle; 🇩🇪 Halle, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany