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Evolocumab for Heart Disease (VESALIUS-CV Trial)
VESALIUS-CV Trial Summary
This trial will see if evolocumab, a cholesterol-lowering drug, can prevent major cardiovascular events in high-risk adults who have not had a heart attack or stroke.
VESALIUS-CV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVESALIUS-CV 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 2020 Phase 4 trial • 259 Patients • NCT03096288VESALIUS-CV Trial Design
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Who is running the clinical trial?
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- Your triglyceride levels are higher than 500 mg/dL in the past 3 months.I am a man over 50 or a woman over 55, but under 80, and meet the cholesterol guidelines.I have not had a heart bypass surgery in the last 3 months.My heart's pumping ability is very weak.I have significant heart, brain, or leg artery disease, or diabetes.I have frequent, uncontrolled heartbeats without a device to correct it.You have at least one significant risk factor.I am scheduled for a procedure to restore blood flow in my arteries.I have atrial fibrillation or flutter and am not on blood thinners.Your cholesterol levels are too high. Your LDL-C is 90 mg/dL or higher, your non-HDL is 120 mg/dL or higher, or your apolipoprotein B is 80 mg/dL or higher.Your kidneys are not filtering blood well enough.I have had a heart attack or stroke before being assigned to a treatment group.A. You have a serious heart artery disease.
B. You have a serious blood vessel disease in your brain.
C. You have a serious blood vessel disease in your arms or legs.
D. You have diabetes.
- Group 1: Placebo
- Group 2: Evolocumab 140 mg Q2W
- 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
Who would be eligible to participate in this experiment?
"Myocardial ischemia patients that are between 50 and 79 years old may qualify for this trial. Right now, the study is looking to enroll around 12,301 people."
Is this study seeking patients that are 25 years or older?
"This research is looking for individuals that fall between 50-79 years old."
How many people total are receiving treatment as part of this experiment?
"This study is not looking for new patients at this moment. The trial was first posted on June 11th, 2019 and last updated December 3rd, 2021. There are presently 1104 other clinical trials actively enrolling patients with myocardial ischemia and 23 studies relating to Evolocumab which are still recruiting participants."
What are physicians concerned about when prescribing Evolocumab?
"There is already some data supporting Evolocumab's efficacy and safety, as this drug has been studied in Phase 3 clinical trials."
What does the Evolocumab clinical trial data tell us about other potential treatments?
"Evolocumab was first trialled in 2018 by the Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley. There are now 18,310 completed studies and 23 trials that are still recruiting patients. Many of these active trials are located in Miami and New york City."
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