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

"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)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; LDL-cholesterol
• Intervention / Treatment: Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Weingärter, MD; Phone Number: 036419324521; Email: oliver.weingaertner@med.uni-jena.de
• Study Contact Backup: Name: Franz Härtel, MD; Email: franz.haertel@med.uni-jena.de

Study Locations

• Germany
  • Berlin, Germany
    • Universitätsmedizin Berlin
  • Dresden, Germany
    • Universitätsklinikum Dresden
  • Essen, Germany
    • Universitätsklinikum Essen
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Halle, Germany
    • Universitätsklinikum Halle
  • Homburg, Germany
    • Universitätsklinikum des Saarlandes
  • Leipzig, Germany
    • Universitätsklinikum Leipzig
    • Contact: Ulrich Laufs, MD
  • Regensburg, Germany
    • Universitätsklinikum Regensburg
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • University Hospital Jena
      • Contact: Oliver Weingaertner, MD; Phone Number: +4936419324521; Email: oliver.weingaertner@med.uni-jena.de
      • Contact: Sissy Grund; Phone Number: +4936419324198; Email: sissy.grund@med.uni-jena.de
      • Sub-Investigator: Aurel Maloku, MD
      • Sub-Investigator: Pellumb Haxhikadrija, MD
      • Sub-Investigator: Jens-Arndt Geiling, MD
      • Sub-Investigator: christian Schulze, MD
      • Principal Investigator: Oliver Weingaertner, MD
      • Sub-Investigator: Franz Haertel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

patients with ST-elevation myocardial infarctions

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cloud-based software; cloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (< 55mg/dl/1.4 mol/L)	Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran; dietary advice for low cholesterol food; Other Names: dietary advice
Placebo Comparator: Standard Care; 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)	Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran; dietary advice for low cholesterol food; Other Names: dietary advice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Oliver Weingärtner, MD, Universitätsklinikum Jena

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: STEMI, NSTEMI; LDL-C; target attainment
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Serine Proteinase Inhibitors; PCSK9 Inhibitors; Evolocumab; Ezetimibe; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Alirocumab
• Other Study ID Numbers: 5219-07/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No