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Clinical Trials/NCT05081336
NCT05081336UnknownNot Applicable

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

University Clinical Centre of Republic of Srpska1 site in 1 country500 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
Major Cardiovascular Adverse Events

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • acute coronary syndrome

Exclusion Criteria

  • Not provided

Arms & Interventions

High-intensity statin

Intervention: Statin (Drug)

High-intensity statin plus ezetimib

Intervention: Statin (Drug)

High-intensity statin plus ezetimib plus PCSK9 inhibitor

Intervention: Statin (Drug)

Outcomes

Primary Outcomes

Major Cardiovascular Adverse Events

Time Frame: 1 year

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

Secondary Outcomes

  • LDL reduction(1 year)

Investigators

Sponsor
University Clinical Centre of Republic of Srpska
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bojan Stanetic

Assistant Prof. Bojan Stanetic, MD, PhD

University Clinical Centre of Republic of Srpska

Study Sites (1)

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