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NCT05587621 Clinical Trial

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

ST Elevation Myocardial Infarction Clinical Trial

— GoT  

Official title:
"Intensive Lipid-Lowering Therapy Guided by a Cloud-based Software System (CLIMEDO GmbH) in Patients With ST-Elevation and Non-ST-Elevation Myocardial Infarctions" (Germany on Target)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05587621
Other study ID # 5219-07/17
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2026

Study information
Verified date September 2023
Source Jena University Hospital
Contact Oliver Weingärter, MD
Phone 036419324521
Email oliver.weingaertner@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
dietary advice for low cholesterol food

Locations
Country Name City State
Germany Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Dresden Dresden
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum Frankfurt Frankfurt
Germany Universitätsklinikum Freiburg Freiburg
Germany Universitätsklinikum Halle Halle
Germany Universitätsklinikum des Saarlandes Homburg
Germany University Hospital Jena Jena Thuringia
Germany Universitätsklinikum Leipzig Leipzig
Germany Universitätsklinikum Regensburg Regensburg

Sponsors (1)
Lead Sponsor Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C LDL-C target attainment (ESC/EAS dyslipidemia guidelines) 6 months
Secondary side-effects of lipid lowering therapy muscle pain, hair loss, dizziness, joint pain, depression 6 months
Secondary adherence to LLT regular LLT 12 months
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