NCT04056169 is a Phase 4 clinical trial of high-dose rosuvastatin in Acute Coronary Syndrome, sponsored by Yuhan Corporation.

Who is sponsoring NCT04056169?

NCT04056169 is sponsored by Yuhan Corporation.

What drugs are being tested in NCT04056169?

Interventions in NCT04056169: high-dose rosuvastatin, low-dose rosuvastatin plus ezetimibe.

What condition does NCT04056169 study?

NCT04056169 studies Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation.

Is NCT04056169 still recruiting?

NCT04056169 is currently completed. Last updated 16 August 2019.

Last reviewed 2019-08-16 · How we verify

NCT04056169

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

Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome

Completed Phase 4 Last updated 16 August 2019

What this trial tests

Phase 4 trial testing high-dose rosuvastatin in Acute Coronary Syndrome in 50 participants. Completed in 23 July 2019.

Timeline

29 June 2017

Primary endpoint
23 July 2019

23 July 2019

Quick facts

Lead sponsor	Yuhan Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	29 June 2017
Primary completion	23 July 2019
Estimated completion	23 July 2019
Sites	2 locations across South Korea

Drugs / interventions tested

high-dose rosuvastatin
low-dose rosuvastatin plus ezetimibe — full drug profile →

Conditions studied

Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
Carotid Atherosclerotic Plaque With Inflammation — all drugs for Carotid Atherosclerotic Plaque With Inflammation →

Sponsor

Yuhan Corporation — full company profile →

Who can join

19 and older, any sex, with Acute Coronary Syndrome or Carotid Atherosclerotic Plaque With Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by \>50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.

Publications & conference data

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

Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.
Khan S, Huda B, Bhurka F, Patnaik R, et al · · 2025 · cited 7× · PMID 40943351 · DOI 10.3390/ijms26178429

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 Yuhan Corporation trials

Trials by the same sponsor.

NCT07470125 — Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers · Phase 1 · not yet recruiting
NCT07415551 — Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1- · Phase 2 · recruiting
NCT07265167 — Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed
NCT07111468 — Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis · Phase 3 · completed
NCT06920719 — Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed

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 NCT04056169 (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 Yuhan Corporation
Last refreshed: 16 August 2019

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/NCT04056169.

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