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RECRUITING
NCT05457582
NA

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

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1212

Start Date

2023-03-30

Completion Date

2030-09-30

Last Updated

2025-06-13

Healthy Volunteers

No

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).

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China