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NCT Number: NCT05587621

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) 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).

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia LDL-cholesterol Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Non-ST Elevation Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Jena, Jena, Thuringia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

Drug

dietary advice for low cholesterol food

Other names: dietary advice

Primary outcomes

  1. LDL-C

    Time frame: 6 months

    LDL-C target attainment (ESC/EAS dyslipidemia guidelines)

Secondary outcomes

  1. side-effects of lipid lowering therapy

    Time frame: 6 months

    muscle pain, hair loss, dizziness, joint pain, depression

  2. adherence to LLT

    Time frame: 12 months

    regular LLT

Study contacts

Contact information is provided by the study sponsor or research team.

Franz Härtel, MD

CONTACT

[email protected]

Oliver Weingärter, MD

CONTACT

[email protected]

036419324521

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study 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)

Acronym: GoT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2022
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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