Who is sponsoring NCT05457582?

NCT05457582 is sponsored by Nanjing First Hospital, Nanjing Medical University.

What drugs are being tested in NCT05457582?

Interventions in NCT05457582: Placebo plus high-intensity statin, PCSK 9 Inhibitor plus high-intensity statin.

What condition does NCT05457582 study?

NCT05457582 studies Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention, Cardiovascular Events.

Is NCT05457582 still recruiting?

NCT05457582 is currently recruiting now. Last updated 13 June 2025.

Last reviewed 2025-06-13 · How we verify

NCT05457582: SHAWN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now NA Last updated 13 June 2025

What this trial tests

NA trial testing Placebo plus high-intensity statin in Acute Coronary Syndrome in 1,212 participants. Currently enrolling.

Timeline

30 March 2023

Primary endpoint
30 September 2026

30 September 2030

Quick facts

Lead sponsor	Nanjing First Hospital, Nanjing Medical University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,212
Start date	30 March 2023
Primary completion	30 September 2026
Estimated completion	30 September 2030
Sites	1 location across China

Drugs / interventions tested

Placebo plus high-intensity statin — full drug profile →
PCSK 9 Inhibitor plus high-intensity statin — full drug profile →

Conditions studied

Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
Hyperlipidemias — all drugs for Hyperlipidemias →
Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
Cardiovascular Events — all drugs for Cardiovascular Events →

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

18 and older, any sex, with Acute Coronary Syndrome or Hyperlipidemias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Current and future role of PCSK9 inhibitors in ASCVD prevention.
Greco A, Capodanno D. · · 2025 · cited 3× · PMID 39757579 · DOI 10.1080/14796678.2025.2450189

Verify or expand the search:

Other recruiting trials for Acute Coronary Syndrome

Currently open trials in the same condition.

NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07230847 — A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug- · NA · recruiting
NCT07032389 — A Polypill for Acute Coronary Syndrome · Phase 2 · recruiting
NCT07102628 — Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronar · Phase 3 · recruiting
NCT06416813 — Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques · NA · active not recruiting

Other Nanjing First Hospital, Nanjing Medical University trials

Trials by the same sponsor.

NCT07349979 — PCI With Guideline-Directed Medical Therapy for HFpEF Patients With Ischemic Cardiomyopathy · NA · not yet recruiting
NCT07505056 — Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas · Phase 3 · not yet recruiting
NCT07397234 — Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation · NA · not yet recruiting
NCT07455448 — Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study · completed
NCT07385885 — Ultrasound-guided Non-invasive Simulation in Anesthesia Residency Training · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05457582 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nanjing First Hospital, Nanjing Medical University
Last refreshed: 13 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05457582.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing