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RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)

Primary Purpose

Cardiovascular Diseases, Cerebrovascular Disease, Peripheral Atherosclerotic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Rosuvastatin plus ezetimibe
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 19-80 years
  • Documented CVD (cardiovascular disease), previous MI(Myocardial Infarction), ACS (Acute Coronary Syndrome), coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD (peripheral artery disease)

Exclusion Criteria:

  • Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range
  • Allergy or hypersensitivity to any statin or ezetimibe
  • Solid organ transplantation recipient
  • History of any adverse drug reaction requiring discontinuation of statin
  • Pregnant women, women with potential childbearing, or lactating women
  • Life expectancy less than 3 years
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed content

Sites / Locations

  • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High-intensity statin monotherapy

Statin plus ezetimibe combination therapy

Arm Description

Statin monotherapy

Statin plus ezetimibe combination therapy

Outcomes

Primary Outcome Measures

Composite of cardiovascular death
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of cardiovascular death
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of cardiovascular death
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Major cardiovascular event
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Major cardiovascular event
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Major cardiovascular event
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of nonfatal stroke
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of nonfatal stroke
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of nonfatal stroke
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)

Secondary Outcome Measures

Clinical efficacy of lipid lowering treatment
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Clinical safety of lipid lowering treatment
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
statin discontinuation and intolerance
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Clinical adverse events
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery

Full Information

First Posted
February 1, 2017
Last Updated
January 10, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03044665
Brief Title
RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
Official Title
RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
February 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more emphasized. However, there are also growing concerns that high-intensity statin would be related to increased risk of adverse effects. In addition, there was an inconsistency of efficacy of statin according to ethnic population. Asian population showed more profound LDL reduction not only from high potent statin but from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cerebrovascular Disease, Peripheral Atherosclerotic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3780 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity statin monotherapy
Arm Type
Active Comparator
Arm Description
Statin monotherapy
Arm Title
Statin plus ezetimibe combination therapy
Arm Type
Experimental
Arm Description
Statin plus ezetimibe combination therapy
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin plus ezetimibe
Intervention Description
Subjects will start single combination pill of rosuvastatin 10 mg plus ezetimibe 10 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level.
Primary Outcome Measure Information:
Title
Composite of cardiovascular death
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 2 months.
Title
Composite of cardiovascular death
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 6 months.
Title
Composite of cardiovascular death
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Title
Major cardiovascular event
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 2 months.
Title
Major cardiovascular event
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 6 months.
Title
Major cardiovascular event
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Title
Composite of nonfatal stroke
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 2 months.
Title
Composite of nonfatal stroke
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at 6 months.
Title
Composite of nonfatal stroke
Description
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Time Frame
Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Secondary Outcome Measure Information:
Title
Clinical efficacy of lipid lowering treatment
Description
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Time Frame
3years
Title
Clinical safety of lipid lowering treatment
Description
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Time Frame
3years
Title
statin discontinuation and intolerance
Description
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Time Frame
3years
Title
Clinical adverse events
Description
The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment) Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.) Statin discontinuation or dose-reduction caused by intolerance new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery
Time Frame
3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 19-80 years Documented CVD (cardiovascular disease), previous MI(Myocardial Infarction), ACS (Acute Coronary Syndrome), coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD (peripheral artery disease) Exclusion Criteria: Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range Allergy or hypersensitivity to any statin or ezetimibe Solid organ transplantation recipient History of any adverse drug reaction requiring discontinuation of statin Pregnant women, women with potential childbearing, or lactating women Life expectancy less than 3 years Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Inability to understand or read the informed content
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang-Soo Jang, MD, PhD
Phone
82-02-2228-8460
Email
jangys1212@yuhs.ac
Facility Information:
Facility Name
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang-Soo Jang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35863366
Citation
Kim BK, Hong SJ, Lee YJ, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Cho YH, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Jang Y, Hong MK; RACING investigators. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-390. doi: 10.1016/S0140-6736(22)00916-3. Epub 2022 Jul 18.
Results Reference
derived

Learn more about this trial

RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)

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