NCT04499859

Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI

A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,548 (estimated)
• Sponsor: Kiyuk Chang, MD,PhD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg. This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.

Detailed description

IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.

Conditions

• Myocardial Infarction
• Statin Adverse Reaction
• HMG-CoA Reductase Inhibitor Toxicity

Interventions

Type	Name	Description
DRUG	Ezetimibe 10mg + Rosuvastatin 5mg	Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
DRUG	Rosuvastatin 20mg	20mg of Rosuvastatin as a standard treatment for AMI patients

Timeline

• Start date: 2020-10-01
• Primary completion: 2026-08-30
• Completion: 2027-08-30
• First posted: 2020-08-05
• Last updated: 2025-07-30

Locations

7 sites across 1 country: South Korea