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

• Sponsor: Kiyuk Chang, MD,PhD (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04499859
• Collaborator: (none)
• Enrollment: 3,548
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site: 506.9
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity	Drug: Rosuzet 10/5 mg; Drug: Rosuvastatin 20mg	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 3548 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ezetimibe 10 mg plus rosuvastatin 5 mg Rosuzet 5/10 mg , once a day for 24 months	Drug: Rosuzet 10/5 mg; Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
Active Comparator: rosuvastatin 20 mg only Any brand drugs of rosuvastatin 20mg, once a day for 24 months	Drug: Rosuvastatin 20mg; 20mg of Rosuvastatin as a standard treatment for AMI patients; Other Names: Crestor 20mg

Outcome Measures

Primary Outcome Measures

1. Major Adverse Cardiovascular Events (MACE) [24 months]

   A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina

Secondary Outcome Measures

1. Each clinical outcome from MACE [24 months]

   Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina

2. Revascularization [24 months]

   any revascularization

3. LDL-C reduction [3 months]

   LDL cholesterol level of 70mg/dL or less

4. Rate of Statin associated muscle symptoms [3 months]

   Stain Associated Muscle Symptom questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adults Aged 19 and up

2. 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)

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

4. Patients who agreed and signed on the informed consent form

Exclusion Criteria:

1. Patients with life expectancy of a year or less due to malignancy

2. Patients with chronic liver disease

3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.

4. Pregnant and/or breastfeeding

5. Female patients who are unable to use any means of contraception

6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease

7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)

8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucheon St.Mary Hospital	Bucheon	Gyeonggido	Korea, Republic of
2	St.Vincent's Hospital	Suwon	Gyeonggido	Korea, Republic of
3	Uijeongbu St.Mary's Hospital	Uijeongbu	Gyeonggido	Korea, Republic of
4	Daejeon St.Mary's Hospital	Daejeon		Korea, Republic of
5	Incheon St.Mary's Hospital	Incheon		Korea, Republic of
6	Seoul St.Mary's Hospital	Seoul		Korea, Republic of	137-701
7	Yeouido St.Mary Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Kiyuk Chang, MD,PhD

Investigators

• Study Chair: Kiyuk Chang, MD,PhD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kiyuk Chang, MD,PhD, Professor of Medicine, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT04499859
• Other Study ID Numbers: ROSUZET-AMI
• First Posted: Aug 5, 2020
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Rosuvastatin Calcium

Study Results

No Results Posted as of Aug 5, 2020