Using PCSK 9 Inhibitor with Statins to Prevent Heart Issues After Heart Procedures

PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

This study is testing if adding a PCSK 9 inhibitor to statin treatment can help prevent heart problems in patients who have had a recent heart issue and a procedure to open their arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1212 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Drugs / interventions: Alirocumab, Tafolecimab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05457582 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of adding a PCSK 9 inhibitor to high-intensity statin therapy in patients who have experienced acute coronary syndrome (ACS) and undergone percutaneous coronary intervention (PCI). The trial compares the outcomes of patients receiving the PCSK 9 inhibitor alongside statins to those receiving a placebo with statins. The primary focus is on reducing cardiovascular events such as heart attacks, strokes, and re-hospitalizations. The study aims to determine if this combination therapy can significantly lower the risk of these events in high-risk ACS patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced acute coronary syndrome and have undergone PCI for culprit lesions.

Not a fit: Patients who have not experienced acute coronary syndrome or those who have not undergone PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cardiovascular events in patients recovering from acute coronary syndrome.

How similar studies have performed: While the combination of PCSK 9 inhibitors and statins has shown promise in other contexts, this specific approach in ACS patients post-PCI is still being explored and may be considered novel.

Eligibility criteria

Inclusion Criteria:

1. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
2. Both male and female subjects aged ≥18 years.
3. Subjects who have experienced an ACS and have undergone PCI for culprit lesions (either QFR or FFR \< 0.8) are eligible. ACS is defined as:

(1) Unstable angina (characterized by rest pain lasting between 5 and 30 minutes or worsening exertional angina accompanied by either transient ST segment depression or elevation, or angiography revealing visually estimated diameter stenosis of 90% or greater, or a ruptured plaque or thrombotic lesion), or (2) Non-ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and non-ST segment elevation, or (3) ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and ST-segment elevation.

4\. Low-density lipoprotein cholesterol levels must meet the following criteria:

1. Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment.
2. Low-density lipoprotein cholesterol ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on a moderate or low-intensity statin regimen before enrollment.
3. Low-density lipoprotein cholesterol ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been on a stable statin regimen for at least 4 weeks before enrollment.

5\. Subjects must have at least one culprit lesion for ACS in a major native coronary artery (diameter stenosis \>70% with a QFR or FFR\<0.8), and have at least one non-culprit vessel disease (diameter stenosis ≤70% with a QFR or FFR ≥0.8).

Exclusion Criteria:

1. Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization.
2. Coronary artery disease is located within a saphenous vein graft or an arterial graft.
3. Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion.
4. TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI.
5. Unstable clinical status, characterized by hemodynamic (including cardiogenic shock) or electrical instability.
6. Uncontrolled hypertension, indicated by multiple readings with systolic blood pressure (SBP) exceeding 180 mmHg or diastolic blood pressure (DBP) exceeding 110 mmHg.
7. New York Heart Association (NYHA) Class III or IV, and an already known left ventricular ejection fraction (LVEF) below 30%.
8. Known history of hemorrhagic stroke in last 180 days before randomization.
9. Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response that has not been controlled by medications in the past 3 months before screening.
10. Severe renal dysfunction, defined by an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m².
11. Active liver disease or hepatic dysfunction.
12. Known intolerance to rosuvastatin or any statin.
13. Known allergy to contrast medium, heparin, aspirin, ticagrelor, prasugrel, or clopidogrel.
14. Subjects who have previously received PCSK9 inhibitors.
15. Subjects who have received cholesterol ester transfer protein inhibitors within the past 12 months before enrollment.
16. Treatment with systemic steroids or systemic cyclosporine within the past 3 months.
17. Known active infection or major hematologic, metabolic, or endocrine dysfunction, as determined by the Investigator.
18. Planned non-cardiac surgery within the next 12 months.
19. Subjects who will not be able to attend the required study visits, as determined by the Investigator.
20. Currently enrolled in another investigational device or drug study.
21. History of cancer within the past 5 years, unless adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer.
22. Estimated life expectancy of less than 12 months.
23. Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy, or hysterectomy.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Shao-Liang Chen, MD, PhD

Conditions Acute Coronary Syndrome; Hyperlipidemias; Percutaneous Coronary Intervention; Cardiovascular Events