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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)

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ClinicalTrials.gov Identifier: NCT03044665
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cerebrovascular Disease Peripheral Atherosclerotic Disease Drug: Rosuvastatin Drug: Rosuvastatin plus ezetimibe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-intensity statin monotherapy
Statin monotherapy
Drug: Rosuvastatin
Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline.

Experimental: Statin plus ezetimibe combination therapy
Statin plus ezetimibe combination therapy
Drug: Rosuvastatin plus ezetimibe
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 Measures :
  1. Composite of cardiovascular death [ Time Frame: Clinical status including medication and clinical events will be evaluated at 2 months. ]
    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.)

  2. Composite of cardiovascular death [ Time Frame: Clinical status including medication and clinical events will be evaluated at 6 months. ]
    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.)

  3. Composite of cardiovascular death [ Time Frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years. ]
    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.)

  4. Major cardiovascular event [ Time Frame: Clinical status including medication and clinical events will be evaluated at 2 months. ]
    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.)

  5. Major cardiovascular event [ Time Frame: Clinical status including medication and clinical events will be evaluated at 6 months. ]
    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.)

  6. Major cardiovascular event [ Time Frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years. ]
    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.)

  7. Composite of nonfatal stroke [ Time Frame: Clinical status including medication and clinical events will be evaluated at 2 months. ]
    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.)

  8. Composite of nonfatal stroke [ Time Frame: Clinical status including medication and clinical events will be evaluated at 6 months. ]
    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.)

  9. Composite of nonfatal stroke [ Time Frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years. ]
    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 :
  1. Clinical efficacy of lipid lowering treatment [ Time Frame: 3years ]
    1. The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment)
    2. 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.)
    3. Statin discontinuation or dose-reduction caused by intolerance
    4. new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery

  2. Clinical safety of lipid lowering treatment [ Time Frame: 3years ]
    1. The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment)
    2. 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.)
    3. Statin discontinuation or dose-reduction caused by intolerance
    4. new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery

  3. statin discontinuation and intolerance [ Time Frame: 3years ]
    1. The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment)
    2. 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.)
    3. Statin discontinuation or dose-reduction caused by intolerance
    4. new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery

  4. Clinical adverse events [ Time Frame: 3years ]
    1. The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment)
    2. 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.)
    3. Statin discontinuation or dose-reduction caused by intolerance
    4. new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044665


Contacts
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Contact: Yang-Soo Jang, MD, PhD 82-02-2228-8460 jangys1212@yuhs.ac

Locations
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Korea, Republic of
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yang-Soo Jang, MD, PhD         
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03044665    
Other Study ID Numbers: 4-2016-1025
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Rosuvastatin Calcium
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors