NCT05587621

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 7, 2024

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

October 17, 2022

Last Update Submit

March 5, 2024

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevation Myocardial InfarctionLDL-cholesterol

Keywords

STEMI, NSTEMI; LDL-C; target attainment

Outcome Measures

Primary Outcomes (1)

  • LDL-C

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

    6 months

Secondary Outcomes (2)

  • side-effects of lipid lowering therapy

    6 months

  • adherence to LLT

    12 months

Study Arms (2)

Cloud-based software

ACTIVE COMPARATOR

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

Standard Care

PLACEBO COMPARATOR

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

Interventions

statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiranDRUG

dietary advice for low cholesterol food

Also known as: dietary advice
Cloud-based softwareStandard Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital Jena

Jena, Thuringia, 07747, Germany

Location

Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsEzetimibe8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidevolocumabalirocumabALN-PCSNutrition Assessment

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Oliver Weingärtner, MD

    Jena University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Weingärter, MD

CONTACT

036419324521oliver.weingaertner@med.uni-jena.de

Franz Härtel, MD

CONTACT

franz.haertel@med.uni-jena.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized trial to compare a cloud-based software system with standard care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

April 1, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 7, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(10)