Acute Coronary SyndromesPhase 3NCT07736313
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients
A Phase 3 study testing PCSK9 inhibitor plus rosuvastatin 20 mg tab and Rosuvastatin 20 Mg Oral Tablet in people with Acute Coronary Syndromes, run by Assiut University.
Trial summary
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD). Percutaneous coronary intervention (PCI) is a key method for revascularization in ASCVD patients, improving their prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- PCSK9 inhibitor plus rosuvastatin 20 mg tab and Rosuvastatin 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18y.o
- Any patient presented with acute coronary syndromes (Myocardial infarction (MI), non-ST elevation Myocardial infarction (NSTEMI), unstable angina) underwent coronary angiography within admission.
- Patients must be diabetic.
- Statin naïve patients at the time of enrollment.
Who cannot join
- patients > 18 y.o
- Patients who have chronic liver disease other than MASLD
- Patients having liver neoplasm
- Patient refused
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does PCSK9 Inhibitor on Top of High Intensity Statin Impact Liver Steatosis Assessed by FibroScan in Diabetic Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes?
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).
- Percutaneous coronary intervention (PCI) is a key method for revascularization in ASCVD patients, improving their prognosis. With the continuous advancement of PCI in recent years, its indications have become increasingly diverse. However, patients still face a pronounced residual risk post-PCI. Research indicates that plaque vulnerability and other risk factors contribute to a 15%-20% rate of major adverse cardiovascular events (MACE) within one year following PCI.
- The pathological mechanism of atherosclerosis is closely tied to the abnormal deposition of low-density lipoprotein cholesterol (LDL-C) beneath the vascular endothelium. This lipid particle can provoke a chronic inflammatory response in the vessel wall, eventually causing plaque formation. Moreover, the marked elevation of LDL-C levels is highly connected to the occurrence and progression of ASCVD.
- Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, with a prevalence of approximately 25% (range 14%-32%).
- It is regarded as the hepatic manifestation of metabolic syndrome (MetS) and is strongly associated with obesity and diabetes mellitus (DM).
- Cardiovascular (CV) disease is one of the leading causes of death in patients with MASLD
- Statins are the cornerstone of lipid-lowering therapy, noticeably diminishing LDL-C levels by blockading HMG-CoA reductase. For patients following PCI, several guidelines suggest high-intensity statin therapy to reach a target LDL-C level of ≤1.4 mmol/L and a ≥50% decline from baseline.
- However, even with intensive statin therapy, many post-PCI patients still exhibit LDL-C levels above the target limits.
- Inhibitors of proprotein convertase subtilisin/kexin type 9(PCSK9) notably decrease plasma LDL-C levels by preventing the binding of PCSK9 protein to LDL-C receptors (LDLR) on hepatocyte surfaces, thereby decreasing LDLR degradation. In 2019, guidelines for managing dyslipidemia from the ESC/EAS emphasize that PCSK9 inhibitors should be added for patients with insufficiently controlled LDL-C levels to achieve the target levels.
- Combining PCSK9 inhibitors with statins has been proven to lead to a 60%-70% reduction in LDL-C levels.
- Recently, a novel non-invasive parameter to assess steatosis has been developed using the Fibroscan® which is a vibration-controlled transient elastography (VCTE™) device used to assess liver elasticity which is related to liver fibrosis. This novel physical parameter, based on the properties of ultrasonic signals acquired by the Fibroscan®, is called the controlled attenuation parameter (CAP). It uses the postulate that fat affects ultrasound propagation, and is a measure of ultrasound attenuation at the central frequency of the Fibroscan
- In this study, the investigators will demonstrate overall effect of PCSK9 inhibitors in combination with statins on MASLD and lipid levels for post-PCI patients, and to compare the degree of risk reduction with statin monotherapy.
- Conditions
- Acute Coronary Syndromes
- Being tested
- PCSK9 inhibitor plus rosuvastatin 20 mg tab, Rosuvastatin 20 Mg Oral Tablet
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitor plus rosuvastatin 20 mg tabDrug
Group of ACS patients \& diagnosed with DM will have PCSK9 inhibitor with rosuvastatin 20 mg tab \& another group will have rosuvastatin 20 mg tab only
Rosuvastatin 20 Mg Oral TabletDrug
only statin given to the patient
| Study group | Role | What they receive |
|---|---|---|
| Case group | Active comparator | will receive PCSK9 inhibitors with rosuvastatin 20mg Receives: Drug: PCSK9 inhibitor plus rosuvastatin 20 mg tab |
| control group | Placebo comparator | Not described Receives: Drug: Rosuvastatin 20 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by Fibroscan, Any change in Liver structure at 6 Months
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Saeed Boules, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736313
- Sponsor's protocol ID
- PCSK9 inhibitors in ACS
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, Song Y, Simonton CA, Gibson CM, Popma JJ, Yeh RW. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. EuroIntervention. 2021 Aug 6;17(5):e380-e387. doi: 10.4244/EIJ-D-19-01031.
PubMed 32863243
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does PCSK9 Inhibitor on Top of High Intensity Statin Impact Liver Steatosis Assessed by FibroScan in Diabetic Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes?
- ClinicalTrials.gov ID
- NCT07736313
- Acronym / sponsor ID
- PCSK9 inhibitors in ACS
- Conditions
- Acute Coronary Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 30 Jul 2026 (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.
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).
- Percutaneous coronary intervention (PCI) is a key method for revascularization in ASCVD patients, improving their prognosis. With the continuous advancement of PCI in recent years, its indications have become increasingly diverse. However, patients still face a pronounced residual risk post-PCI. Research indicates that plaque vulnerability and other risk factors contribute to a 15%-20% rate of major adverse cardiovascular events (MACE) within one year following PCI.
- The pathological mechanism of atherosclerosis is closely tied to the abnormal deposition of low-density lipoprotein cholesterol (LDL-C) beneath the vascular endothelium. This lipid particle can provoke a chronic inflammatory response in the vessel wall, eventually causing plaque formation. Moreover, the marked elevation of LDL-C levels is highly connected to the occurrence and progression of ASCVD.
- Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, with a prevalence of approximately 25% (range 14%-32%).
- It is regarded as the hepatic manifestation of metabolic syndrome (MetS) and is strongly associated with obesity and diabetes mellitus (DM).
- Cardiovascular (CV) disease is one of the leading causes of death in patients with MASLD
- Statins are the cornerstone of lipid-lowering therapy, noticeably diminishing LDL-C levels by blockading HMG-CoA reductase. For patients following PCI, several guidelines suggest high-intensity statin therapy to reach a target LDL-C level of ≤1.4 mmol/L and a ≥50% decline from baseline.
- However, even with intensive statin therapy, many post-PCI patients still exhibit LDL-C levels above the target limits.
- Inhibitors of proprotein convertase subtilisin/kexin type 9(PCSK9) notably decrease plasma LDL-C levels by preventing the binding of PCSK9 protein to LDL-C receptors (LDLR) on hepatocyte surfaces, thereby decreasing LDLR degradation. In 2019, guidelines for managing dyslipidemia from the ESC/EAS emphasize that PCSK9 inhibitors should be added for patients with insufficiently controlled LDL-C levels to achieve the target levels.
- Combining PCSK9 inhibitors with statins has been proven to lead to a 60%-70% reduction in LDL-C levels.
- Recently, a novel non-invasive parameter to assess steatosis has been developed using the Fibroscan® which is a vibration-controlled transient elastography (VCTE™) device used to assess liver elasticity which is related to liver fibrosis. This novel physical parameter, based on the properties of ultrasonic signals acquired by the Fibroscan®, is called the controlled attenuation parameter (CAP). It uses the postulate that fat affects ultrasound propagation, and is a measure of ultrasound attenuation at the central frequency of the Fibroscan
- In this study, the investigators will demonstrate overall effect of PCSK9 inhibitors in combination with statins on MASLD and lipid levels for post-PCI patients, and to compare the degree of risk reduction with statin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Active comparator | Drug: PCSK9 inhibitor plus rosuvastatin 20 mg tabwill receive PCSK9 inhibitors with rosuvastatin 20mg |
| control group | Placebo comparator | Drug: Rosuvastatin 20 Mg Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18y.o
- Any patient presented with acute coronary syndromes (Myocardial infarction (MI), non-ST elevation Myocardial infarction (NSTEMI), unstable angina) underwent coronary angiography within admission.
- Patients must be diabetic.
- Statin naïve patients at the time of enrollment.
Key exclusion criteria (4 listed)
- patients > 18 y.o
- Patients who have chronic liver disease other than MASLD
- Patients having liver neoplasm
- Patient refused
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 |
|---|---|---|
| PCSK9 inhibitor plus rosuvastatin 20 mg tabGroup of ACS patients \& diagnosed with DM will have PCSK9 inhibitor with rosuvastatin 20 mg tab \& another group will have rosuvastatin 20 mg tab only | Drug | Case group |
| Rosuvastatin 20 Mg Oral Tabletonly statin given to the patient | Drug | control group |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by Fibroscan, Any change in Liver structure at 6 Months
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Results publication: PubMed 32863243Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, Song Y, Simonton CA, Gibson CM, Popma JJ, Yeh RW. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. EuroIntervention. 2021 Aug 6;17(5):e380-e387. doi: 10.4244/EIJ-D-19-01031.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCSK9 inhibitor plus rosuvastatin 20 mg tab and Rosuvastatin 20 Mg Oral Tablet in people with Acute Coronary Syndromes, run by Assiut University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Saeed Boules, resident doctor (+201559724062, Christinasaeed3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by Fibroscan, Any change in Liver structure at 6 Months (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736313, which also lists 1 linked publication.
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 30 Jul 2026.