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Evolocumab Injections for Coronary Artery Disease (YELLOW III Trial)
YELLOW III Trial Summary
This trial is looking at whether or not evolocumab can help to improve coronary plaque morphology in patients with stable CAD who are already taking statins. The trial will use intravascular imaging and gene expression analysis of peripheral blood mononuclear cells to assess the effect of evolocumab.
- Coronary Artery Disease
YELLOW III Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 4 trial • 137 Patients • NCT04710368YELLOW III Trial Design
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Who is running the clinical trial?
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- You have an ongoing autoimmune disease.You are experiencing a severe heart condition called cardiogenic shock.You have blockages in the main artery of your heart, or you have had previous procedures to open up blocked arteries, or you need a type of heart surgery called coronary artery bypass graft.
- Group 1: Treatment
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What key outcomes is this clinical trial attempting to achieve?
"The primary outcome measure of this trial over the baseline period and 26 weeks is a change in minimal fibrous cap thickness (FCT). Secondary outcomes include changes to lipid length, macrophage accumulation, and calcification accumulation as measured by optical coherence tomography (OCT) expressed in millimetres."
Are participants currently being accepted for this experiment?
"According to the information provided on clinicaltrials.gov, this trial is accepting applications from potential candidates. It was initially launched on 4th May 2021 and its details were last updated a year later, on 4th May 2022."
How many individuals can potentially partake in this research study?
"Indeed. According to the information published on clinicaltrials.gov, this experimental trial is presently accepting participants. The investigation was initially posted on May 4th 2021 and its details have been refreshed as of May 4th 2022; a total of 140 individuals must be recruited from 1 specialized site."
Has this experimental research been conducted before?
"Evolocumab Injections has been a subject of research since 2018, when Hoffmann-La Roche initiated their first study with 435 subjects. Later that year the drug received approval through Phase 1 & 2 trials, and currently there are 22 active studies occurring in 35 nations spread across 240 cities."
Has Evolocumab Injections been granted regulatory clearance by the FDA?
"The safety of Evolocumab Injections has been affirmed, with the Phase 4 trial providing sufficient evidence to earn it a score of 3."
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