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

NCT05081336 | Unknown

• 1 other identifier: 022021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Major Cardiovascular Adverse Events

  All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization

  1 year

Secondary Outcomes (1)

• LDL reduction

  1 year

Study Arms (3)

High-intensity statin

Drug: Statin

High-intensity statin plus ezetimib

Drug: Statin

High-intensity statin plus ezetimib plus PCSK9 inhibitor

Drug: Statin

Interventions

Statin DRUG

Statin +/- ezetimib +/- Alirocumab

Also known as: Ezetimib, Alirocumab

High-intensity statin; High-intensity statin plus ezetimib; High-intensity statin plus ezetimib plus PCSK9 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• acute coronary syndrome

Sponsors & Collaborators

• University Clinical Centre of Republic of Srpska: lead

Study Sites (1)

University Clinical Centre of the Republic of Srpska

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Dyslipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe; alirocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bojan M Stanetic, MD, PhD

  University Clinical Centre of the Republic of Srpska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bojan M Stanetic, MD, PhD

CONTACT

0038765614340; bojan.stanetic@gmail.com

Tamara S Kovacevic-Preradovic, MD, PhD

CONTACT

tamara.preradovic@medicolaser.info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof. Bojan Stanetic, MD, PhD

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BO (1)