PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI

NCT05457582 | Recruiting DMC

• 1 other identifier: NMU20220701
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Cardiovascular events defined as the composite of cardiovascular death, myocardial infarction, stroke or transit ischemic attack, re-hospitalization due to unstable angina or heart failure, or any ischemia-driven coronary revascularization.

  12 months after randomization

Secondary Outcomes (8)

• Cardiovascular death

  12 months after randomization

• All cause death

  12 months after randomization

• Myocardial infarction

  12 months after randomization

• Stroke

  12 months after randomization

• Ischemia-driven coronary revascularization

  12 months after randomization

Study Arms (2)

Placebo plus high-intensity statin

PLACEBO COMPARATOR

Participants received placebo subcutaneous injections once every 2 weeks (Q2W) plus high-intensity statin treatment (Rosuvastatin, 20 mg, once daily)

Drug: Placebo plus high-intensity statin

PCSK 9 Inhibitor plus high-intensity statin

ACTIVE COMPARATOR

Participants received PCSK 9 Inhibitor Q2W subcutaneous injections

Drug: PCSK 9 Inhibitor plus high-intensity statin

Interventions

Placebo plus high-intensity statin DRUG

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).

Placebo plus high-intensity statin

PCSK 9 Inhibitor plus high-intensity statin DRUG

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).

PCSK 9 Inhibitor plus high-intensity statin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Both male and female subjects aged ≥18 years.
• 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.
• \. Low-density lipoprotein cholesterol levels must meet the following criteria:
• 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.
• 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.
• 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.
• \. 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).

You may not qualify if:

• Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization.
• Coronary artery disease is located within a saphenous vein graft or an arterial graft.
• Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion.
• TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI.
• Unstable clinical status, characterized by hemodynamic (including cardiogenic shock) or electrical instability.
• Uncontrolled hypertension, indicated by multiple readings with systolic blood pressure (SBP) exceeding 180 mmHg or diastolic blood pressure (DBP) exceeding 110 mmHg.
• New York Heart Association (NYHA) Class III or IV, and an already known left ventricular ejection fraction (LVEF) below 30%.
• Known history of hemorrhagic stroke in last 180 days before randomization.
• 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.
• Severe renal dysfunction, defined by an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m².
• Active liver disease or hepatic dysfunction.
• Known intolerance to rosuvastatin or any statin.
• Known allergy to contrast medium, heparin, aspirin, ticagrelor, prasugrel, or clopidogrel.
• Subjects who have previously received PCSK9 inhibitors.
• Subjects who have received cholesterol ester transfer protein inhibitors within the past 12 months before enrollment.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• National Natural Science Foundation of China: collaborator
• Nanjing Medical University: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Hyperlipidemias

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Shao-Liang Chen, MD, PhD

CONTACT

+86-25-52271351; chmengx@126.com

Jing Kan, MPH

CONTACT

+86-25-52271398; kanjingok@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participants nor the investigators are aware of the treatment assignment until the end of the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Nanjing First Hospital, Director of Cardiovascular Department

Model Details: Participants are randomly (at a ratio of 1:1) assigned to PCSK9 inhibitor plus high-intensity statin or placebo plus high-intensity statin group, and then the results at 1 year, 2- or 3-year are compared

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 14, 2022
• Study Start: March 30, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)