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

Who is this study for? Patients with Myocardial Infarction, Statin Adverse Reaction
What treatments are being studied? Rosuvastatin
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Adults Aged 19 and up

• Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)

• For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test

• Patients who agreed and signed on the informed consent form

Locations
Other Locations
Republic of Korea
Bucheon St.Mary Hospital
RECRUITING
Bucheon-si
Daejeon St.Mary's Hospital
RECRUITING
Daejeon
Incheon St.Mary's Hospital
RECRUITING
Incheon
Seoul St.Mary's Hospital
RECRUITING
Seoul
Yeouido St.Mary Hospital
RECRUITING
Seoul
St.Vincent's Hospital
RECRUITING
Suwon
Uijeongbu St.Mary's Hospital
RECRUITING
Uijeongbu-si
Contact Information
Primary
Kiyuk Chang, MD,PhD
kiyuk@catholic.ac.kr
82-10-9175-2076
Backup
Eun Ho Choo, MD
cmcchu@catholic.ac.kr
82-10-8500-4569
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2027-08-30
Participants
Target number of participants: 3548
Treatments
Experimental: ezetimibe 10 mg plus rosuvastatin 5 mg
Rosuzet 5/10 mg , once a day for 24 months
Active_comparator: rosuvastatin 20 mg only
Any brand drugs of rosuvastatin 20mg, once a day for 24 months
Sponsors
Leads: Kiyuk Chang, MD,PhD

This content was sourced from clinicaltrials.gov

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