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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT04719221 |
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Date of registration:
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12/01/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome
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Scientific title:
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A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome |
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Date of first enrolment:
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March 2021 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04719221 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jung-Joon Cha, MD, PhD |
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Address:
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Telephone:
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821089534950 |
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Email:
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joonletter@hanmail.net |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Over 19 years old
2. Patients who agree to the study plan and clinical follow-up plan, voluntarily decide
to participate in this study, and consent in writing to the consent to use information
3. Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary
syndrome
4. Patients who did not meet the LDL-Cholesterol level (<70mg/dL) even after receiving
the maximum dose of combined cholesterol therapy for 2 months
Exclusion Criteria:
1. Subjects with known hypersensitivity or contraindications to the following drugs or
substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin,
ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And
contrast agents (however, even a subject who is hypersensitive to contrast agents can
register if they can be controlled by steroids and pheniramine, except for known
anaphylaxis.)
2. Pregnant women, lactating women, or women of childbearing age who plan to become
pregnant during this study
3. Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from
registration
4. Those whose surviving life is expected to be less than 1 year
5. Subjects who visited the hospital due to psychogenic shock and are predicted to have
low survival probability based on medical judgment
6. Subjects participating in a randomized study on cholesterol therapy
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Coronary Syndrome
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Clinical Trial
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Intervention(s)
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Device: NIRS IVUS
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Drug: Evolocumab
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Primary Outcome(s)
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Change of 1-year lipid core burden index
[Time Frame: 1 year]
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Secondary Outcome(s)
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patient-oriented composite end point
[Time Frame: 1 year]
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Percentage of All cause mortality
[Time Frame: 1 year]
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Percentage of cardiac death
[Time Frame: 1 year]
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Percentage of myocardial infarction
[Time Frame: 1 year]
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Percentage of revascularization
[Time Frame: 1 year]
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Rate of usage of cholesterol lowering agents (12 month)
[Time Frame: 1 year]
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Rate of usage of cholesterol lowering agents (2 month)
[Time Frame: 1 year]
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Secondary ID(s)
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ELoNirs-ACS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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