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

NCT ID: NCT05081336

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome Dyslipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High-intensity statin

Statin

Intervention Type DRUG

Statin +/- ezetimib +/- Alirocumab

High-intensity statin plus ezetimib

Statin

Intervention Type DRUG

Statin +/- ezetimib +/- Alirocumab

High-intensity statin plus ezetimib plus PCSK9 inhibitor

Statin

Intervention Type DRUG

Statin +/- ezetimib +/- Alirocumab

Interventions

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Statin

Statin +/- ezetimib +/- Alirocumab

Intervention Type DRUG

Other Intervention Names

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Ezetimib Alirocumab

Eligibility Criteria

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Inclusion Criteria

* acute coronary syndrome

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Clinical Centre of Republic of Srpska

OTHER

Sponsor Role lead

Responsible Party

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Bojan Stanetic

Assistant Prof. Bojan Stanetic, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bojan M Stanetic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Centre of the Republic of Srpska

Locations

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University Clinical Centre of the Republic of Srpska

Banja Luka, Republika Srpska, Bosnia and Herzegovina

Site Status RECRUITING

Countries

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Bosnia and Herzegovina

Central Contacts

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Bojan M Stanetic, MD, PhD

Role: CONTACT

0038765614340

Tamara S Kovacevic-Preradovic, MD, PhD

Role: CONTACT

Facility Contacts

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Bojan M Stanetic, MD, PhD

Role: primary

0038765614340

Other Identifiers

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022021

Identifier Type: -

Identifier Source: org_study_id