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JaZ: Intensive Lipid-lowering in Patients With STEMI

Sponsor
Jena University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05587621
Collaborator
(none)
1,000
Enrollment
1
Location
52.3
Anticipated Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients admitted to the Jena University Hospital with ST-elevation myocardial infarctions will be closely followed-up to achieve ESC/EAS-guideline recommended LDL-cholesterol goals.

Condition or Disease Intervention/Treatment Phase
  • Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

Detailed Description

Patients admitted to the Jena University Hospital (UKS) with an ST-elevation myocardial infarction (STEMI) will be closely monitored to achieve ESC/EAS-guideline recommended LDL-cholesterol goals. Lipid profiles of each patient will be evaluated on the day of admission, on discharge and during follow-ups at 4-8 weeks, 6 months and 12 months after the index event. If the ESC/EAS-guideline LDL-C target is not attained with a statin and ezetimibe, then escalation of lipid-lowering therapy accordling to the current ESC/EAS dyslipidemia guidelines with either bempedoic acid, PCSK9mabs or inclisiran is indicated.

Lipid profils, in particular LDL-c goal attainment and lipid-lowering treatment will be documented in patients cards.The aim is to get all patients on ESC/EAS LDL-C targets.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intensive Lipid-lowering Therapy for Early Achievement of Guideline-recommended LDL Cholesterol Levels in Patients With ST-elevation Myocardial Infarctions
Actual Study Start Date :
Aug 23, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Outcome Measures

Primary Outcome Measures

  1. LDL-C [24 months]

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

Secondary Outcome Measures

  1. reasons for changes in lipid-lowering therapy [24 months]

    reasons for changes in lipid-lowering therapy, e.g. LDL-C goal not attained

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • patients with ST-elevation myocardial infarctions
Exclusion Criteria:

  • patient without informed concent

  • patients in cardiogenic shock

  • patients with contraindication to lipid-lowering therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Jena Jena Thuringia Germany 07747

Sponsors and Collaborators

  • Jena University Hospital

Investigators

  • Principal Investigator: Oliver Weingärtner, MD, Universitätsklinikum Jena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jena University Hospital
ClinicalTrials.gov Identifier:
NCT05587621
Other Study ID Numbers:
  • 5219-07/17
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Ezetimibe
Evolocumab

Study Results

No Results Posted as of Oct 20, 2022