Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry (RS-ACS)

October 17, 2021 updated by: Bojan Stanetic, University Clinical Centre of Republic of Srpska

Recent trials have demonstrated that a reduction in low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular adverse events following acute coronary syndrome (ACS). However, the data coming from the real-world setting are limited. Therefore, the aim of the study is to assess the association between LDL-C changes with prognosis in patients who survive ACS.

Patients with ACS will be followed for mortality and major events for at least 1 year. Changes in LDL-C between the ACS and a 6- to 10-week follow-up visit will be analysed. The associations between quartiles of LDL-C change and therapy intensity with outcomes will be investigated using adjusted Cox regression analyses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bosnia and Herzegovina
    • Republic Of Srpska
      • Banja Luka, Republic Of Srpska, Bosnia and Herzegovina, 78000
        • Recruiting
        • University Clinical Centre of the Republic of Srpska
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients presented with acute coronary syndrome in one of hospitals in Republic of Srpska

Description

Inclusion Criteria:

  • acute coronary syndrome

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-intensity statin
Drug: Statin
Statin +/- ezetimib +/- Alirocumab
Other Names:
  • Alirocumab
  • Ezetimib
High-intensity statin plus ezetimib
Drug: Statin
Statin +/- ezetimib +/- Alirocumab
Other Names:
  • Alirocumab
  • Ezetimib
High-intensity statin plus ezetimib plus PCSK9 inhibitor
Drug: Statin
Statin +/- ezetimib +/- Alirocumab
Other Names:
  • Alirocumab
  • Ezetimib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Cardiovascular Adverse Events
Time Frame: 1 year
All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL reduction
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinical Centre of Republic of Srpska

Investigators

  • Principal Investigator: Bojan M Stanetic, MD, PhD, University Clinical Centre of the Republic of Srpska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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