Acute Coronary SyndromeRS-ACSNCT05081336
Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry
An observational study of Acute Coronary Syndrome and Dyslipidemias, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Dyslipidemias
- What is being tested?
- Statin
- How many people
- 500 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Mar 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients presented with acute coronary syndrome in one of hospitals in Republic of Srpska
Who may be able to join
- acute coronary syndrome
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Tamara S Kovacevic-Preradovic, MD, PhD contact
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Centre of the Republic of Srpska
Banja Luka, Republika Srpska, 78000
Bojan M Stanetic, MD, PhD, 0038765614340, bojan.stanetic@gmail.com
About this study
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
- Being tested
- Statin
- Medical subject headings
- Acute Coronary Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called Ezetimib, Alirocumab
Statin +/- ezetimib +/- Alirocumab
| Study group | Role | What they receive |
|---|---|---|
| High-intensity statin | Not described Receives: Drug: Statin | |
| High-intensity statin plus ezetimib | Not described Receives: Drug: Statin | |
| High-intensity statin plus ezetimib plus PCSK9 inhibitor | Not described Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiovascular Adverse Events
All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization
Measured: 1 year
Secondary outcomes (1)
LDL reduction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Mar 2021
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Republic of Srpska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Stanetic, University Clinical Centre of Republic of Srpska
- Investigators
- Bojan M Stanetic, MD, PhD, Principal investigator, University Clinical Centre of the Republic of Srpska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081336
- Sponsor's protocol ID
- 022021
- Acronym
- RS-ACS
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05081336
- Acronym / sponsor ID
- RS-ACS / 022021
- Conditions
- Acute Coronary Syndrome, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Clinical Centre of Republic of SrpskaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity statin | – | Drug: Statin |
| High-intensity statin plus ezetimib | – | Drug: Statin |
| High-intensity statin plus ezetimib plus PCSK9 inhibitor | – | Drug: Statin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presented with acute coronary syndrome in one of hospitals in Republic of Srpska
Key inclusion criteria (1 listed)
- acute coronary syndrome
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinAlso: Ezetimib, AlirocumabStatin +/- ezetimib +/- Alirocumab | Drug | High-intensity statin, High-intensity statin plus ezetimib, High-intensity statin plus ezetimib plus PCSK9 inhibitor |
Primary outcome
Major Cardiovascular Adverse Events
Time frame: 1 year
All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization
1 secondary outcome
LDL reduction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara S Kovacevic-Preradovic, MD, PhD contact
Bojan M Stanetic, MD, PhD principal investigator
University Clinical Centre of the Republic of Srpska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Dyslipidemias, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan M Stanetic, MD, PhD (0038765614340, bojan.stanetic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiovascular Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.