Low-density Lipoprotein Cholesterol Reduction With State-... | NCT05081336

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2021

Last Update Posted Date

Oct 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bojan Stanetic, Assistant Prof. Bojan Stanetic, MD, PhD, University Clinical Centre of Republic of SrpskaPrincipal Investigator

Lead Sponsor

University Clinical Centre of Republic of SrpskaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-intensity statin			Drug: Statin
High-intensity statin plus ezetimib			Drug: Statin
High-intensity statin plus ezetimib plus PCSK9 inhibitor			Drug: Statin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Statin	Drug	Statin +/- ezetimib +/- Alirocumab	High-intensity statin High-intensity statin plus ezetimib High-intensity statin plus ezetimib plus PCSK9 inhibitor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
LDL reduction		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute coronary syndrome

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bojan M Stanetic, MD, PhD	Contact	0038765614340		bojan.stanetic@gmail.com
Tamara S Kovacevic-Preradovic, MD, PhD	Contact			tamara.preradovic@medicolaser.info

Overall Officials

Name	Affiliation	Role
Bojan M Stanetic, MD, PhD	University Clinical Centre of the Republic of Srpska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Centre of the Republic of Srpska	Recruiting	Banja Luka	Republika Srpska	78000	Bosnia and Herzegovina

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

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

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D050171	Dyslipidemias

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D000069438	Ezetimibe
C571059	alirocumab

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004791	Enzyme Inhibitors
D057847	Lipid Regulating Agents
D045506	Therapeutic Uses
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds