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ST Elevation Myocardial InfarctionGoTNCT05587621

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

A study testing statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran in people with ST Elevation Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Jena University Hospital at 10 sites in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
10 sitesGermany
Study dates
1 Apr 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oliver Weingärter, MD contact

036419324521

oliver.weingaertner@med.uni-jena.de

Franz Härtel, MD contact

franz.haertel@med.uni-jena.de

10 sites in 1 country

Germany10 sites

  • Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Dresden

    Dresden

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Universitätsklinikum Halle

    Halle

  • Universitätsklinikum des Saarlandes

    Homburg

  • University Hospital Jena

    Jena, Thuringia, 07747

    Oliver Weingaertner, MD, +4936419324521, oliver.weingaertner@med.uni-jena.de

    Sissy Grund, +4936419324198, sissy.grund@med.uni-jena.de

  • Universitätsklinikum Leipzig

    Leipzig

    Ulrich Laufs, MD

  • Universitätsklinikum Regensburg

    Regensburg

Other trials in Germany

About this study

Official 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)

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).

Read the 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.

Being tested
statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
Keywords
STEMI, NSTEMI; LDL-C; target attainment
Medical subject headings
ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiranDrug

    Also called dietary advice

    dietary advice for low cholesterol food

Study groups in NCT05587621
Study groupRoleWhat they receive
Cloud-based softwareActive comparatorcloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (< 55mg/dl/1.4 mol/L)
Receives: Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
Standard CarePlacebo comparatorPatients 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)
Receives: Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL-C

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

    Measured: 6 months

Secondary outcomes (2)

  1. side-effects of lipid lowering therapy

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

    Measured: 6 months

  2. adherence to LLT

    regular LLT

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized trial to compare a cloud-based software system with standard care
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587621
Sponsor's protocol ID
5219-07/17
Acronym
GoT
Status last verified
Sep 2023
First submitted
17 Oct 2022
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran in people with ST Elevation Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Jena University Hospital at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oliver Weingärter, MD (036419324521, oliver.weingaertner@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05587621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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