Clincosm LogoSign in Get a demo

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

Sponsor
University Clinical Centre of Republic of Srpska (Other)
Overall Status
Recruiting
CT.gov ID
NCT05081336
Collaborator
(none)
500
Enrollment
1
Location
24
Anticipated Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
High-intensity statin

Drug: Statin
Statin +/- ezetimib +/- Alirocumab
Other Names:
  • Ezetimib
  • Alirocumab

    		•
    High-intensity statin plus ezetimib

    Drug: Statin
    Statin +/- ezetimib +/- Alirocumab
    Other Names:
  • Ezetimib
  • Alirocumab

    		•
    High-intensity statin plus ezetimib plus PCSK9 inhibitor

    Drug: Statin
    Statin +/- ezetimib +/- Alirocumab
    Other Names:
  • Ezetimib
  • Alirocumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major Cardiovascular Adverse Events [1 year]

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

    Secondary Outcome Measures

    1. LDL reduction [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • acute coronary syndrome
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Clinical Centre of the Republic of Srpska Banja Luka Republic Of Srpska Bosnia and Herzegovina 78000

    Sponsors and Collaborators

    • University Clinical Centre of Republic of Srpska

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bojan Stanetic, Assistant Prof. Bojan Stanetic, MD, PhD, University Clinical Centre of Republic of Srpska
    ClinicalTrials.gov Identifier:
    NCT05081336
    Other Study ID Numbers:
    • 022021
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Dyslipidemias
    Ezetimibe

    Study Results

    No Results Posted as of Oct 25, 2021