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

NCT05457582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1212

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

DRUG

Placebo plus high-intensity statin

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

DRUG

PCSK 9 Inhibitor plus high-intensity statin

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

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Nanjing Medical University

    collaborator OTHER

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Shao-Liang Chen, MD, PhD · Nanjing First Hospital, Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2026-09-30
Completion
2030-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457582 on ClinicalTrials.gov