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

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)

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05587621

Acronym

GoT

Enrollment

300

Registered

2022-10-20

Start date

2024-04-01

Completion date

2026-12-31

Last updated

2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LDL-cholesterol, Non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction

Keywords

STEMI, NSTEMI; LDL-C; target attainment

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.

Interventions

DRUGstatins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

dietary advice for low cholesterol food

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

randomized trial to compare a cloud-based software system with standard care

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
LDL-C	6 months	LDL-C target attainment (ESC/EAS dyslipidemia guidelines)

Secondary

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

Countries

Germany

Contacts

Primary ContactOliver Weingärter, MD

oliver.weingaertner@med.uni-jena.de036419324521

Backup ContactFranz Härtel, MD

franz.haertel@med.uni-jena.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026