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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ezetimibe 10mg + Rosuvastatin 5mg
Rosuvastatin 20mg
Sponsored by
Kiyuk Chang, MD,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Bucheon St.Mary HospitalRecruiting
  • St.Vincent's HospitalRecruiting
  • Uijeongbu St.Mary's HospitalRecruiting
  • Daejeon St.Mary's HospitalRecruiting
  • Incheon St.Mary's HospitalRecruiting
  • Seoul St.Mary's HospitalRecruiting
  • Yeouido St.Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ezetimibe 10 mg plus rosuvastatin 5 mg

rosuvastatin 20 mg only

Arm Description

Rosuzet 5/10 mg , once a day for 24 months

Any brand drugs of rosuvastatin 20mg, once a day for 24 months

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina

Secondary Outcome Measures

Each clinical outcome from MACE
Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina
Revascularization
any revascularization
LDL-C reduction
LDL cholesterol level of 70mg/dL or less
Rate of Statin associated muscle symptoms
Stain Associated Muscle Symptom questionnaire

Full Information

First Posted
July 29, 2020
Last Updated
September 2, 2022
Sponsor
Kiyuk Chang, MD,PhD
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1. Study Identification

Unique Protocol Identification Number
NCT04499859
Brief Title
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Acronym
ROSUZET-AMI
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kiyuk Chang, MD,PhD

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ezetimibe 10 mg plus rosuvastatin 5 mg
Arm Type
Experimental
Arm Description
Rosuzet 5/10 mg , once a day for 24 months
Arm Title
rosuvastatin 20 mg only
Arm Type
Active Comparator
Arm Description
Any brand drugs of rosuvastatin 20mg, once a day for 24 months
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 10mg + Rosuvastatin 5mg
Other Intervention Name(s)
Rosuzet 10/5 mg
Intervention Description
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Other Intervention Name(s)
Crestor 20mg
Intervention Description
20mg of Rosuvastatin as a standard treatment for AMI patients
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events (MACE)
Description
A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Each clinical outcome from MACE
Description
Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina
Time Frame
24 months
Title
Revascularization
Description
any revascularization
Time Frame
24 months
Title
LDL-C reduction
Description
LDL cholesterol level of 70mg/dL or less
Time Frame
3 months
Title
Rate of Statin associated muscle symptoms
Description
Stain Associated Muscle Symptom questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with life expectancy of a year or less due to malignancy Patients with chronic liver disease 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. Pregnant and/or breastfeeding Female patients who are unable to use any means of contraception Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study) Patients considered inappropriate for the study for any other reason(s) by the inspector(s)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyuk Chang, MD,PhD
Phone
82-10-9175-2076
Email
kiyuk@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Ho Choo, MD
Phone
82-10-8500-4569
Email
cmcchu@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang, MD,PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bucheon St.Mary Hospital
City
Bucheon
State/Province
Gyeonggido
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Yeol Kim, M.D.
Facility Name
St.Vincent's Hospital
City
Suwon
State/Province
Gyeonggido
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-Dong Yoo, M.D.
Facility Name
Uijeongbu St.Mary's Hospital
City
Uijeongbu
State/Province
Gyeonggido
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, M.D.
Facility Name
Daejeon St.Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Won Park, M.D.
Facility Name
Incheon St.Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doo Soo Jeon, M.D.
Facility Name
Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang, M.D.
Facility Name
Yeouido St.Mary Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-Soo Park, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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