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Evolocumab for Coronary Artery Bypass Surgery (NEWTON-CABG Trial)
NEWTON-CABG Trial Summary
This trial will test whether evolocumab, when added to statin therapy, can improve the health of veins used in bypass surgery.
- Atherosclerosis
- Coronary Artery Bypass Surgery
- Venous Occlusion
NEWTON-CABG 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 • NCT03096288NEWTON-CABG Trial Design
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- It's not suitable for you to take evolocumab to further lower your LDL cholesterol.You are allergic to the dye used for medical imaging tests.You have severe liver problems.You are allergic to evolocumab or other similar medications.You have a serious heart or other health condition that is likely to make your life expectancy less than 2 years.You are planning to have heart surgery to fix blocked arteries or repair or replace heart valves.You have had or are planning to have a specific type of heart surgery using veins from your leg.You are currently taking, have taken in the past year, or plan to take PCSK9 inhibition treatment.You are currently taking more than 40mg of simvastatin per day, niacin, or bile acid sequestrants.You have had a major organ transplant, such as lung, liver, heart, or bone marrow.You have a serious infection or a major health problem with your blood, kidneys, lungs, metabolism, digestion, or hormones.You had cancer in the last 5 years, except for certain types of early-stage or treated skin and prostate cancers.You have severe heart failure.You have had fewer than 2 vein grafts.You had heart bypass surgery in the last three weeks, or you're going to have it in the next two months.You have taken a certain kind of medication to lower cholesterol within the last year.You had serious complications after heart bypass surgery before joining the study.You are taking a strong cholesterol-lowering medicine, unless your doctor says a different dose or type of medicine is better for you.You have kidney disease with a low estimated glomerular filtration rate (eGFR).
- Group 1: Evolocumab Treatment
- Group 2: Placebo Treatment
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 evidence exists demonstrating the efficacy and security of Evolocumab for patients?
"Clinicians have concluded that evolocumab is safe and rated it a 3 on our scale, as this medication has already been approved for clinical use."
Are participants being enrolled at this point in the clinical trial?
"This clinical trial is currently recruiting, as seen on the data posted to clinicaltrials.gov since its inception on May 30th 2019 and most recently edited July 9th 2020."
What other investigations have taken place concerning the utilization of Evolocumab?
"Evolocumab was initially studied in 2018 at Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley and has seen 18362 completed clinical trials. Presently, there are 22 active studies predominantly taking place near Portland, Maine."
How many individuals have been recruited for this experiment?
"This clinical trial requires 766 participants that meet the requisite inclusion criteria. Individuals who are interested in partaking can do so through either Maine Medical Center (Portland, Maine) or University of Alberta (Edmonton, Alberta)."
What are the various locales where this research endeavor is taking place?
"The current medical trial is enrolling patients from 9 distinct sites, located in the cities of Portland, Edmonton and Québec among others. To reduce travel requirements, it would be beneficial to select a centre closest to your home."
Is this medical trial the inaugural effort of its type?
"Since 2018, Hoffmann-La Roche has spearheaded the scientific exploration of Evolocumab. This biopharmaceutical product was granted Phase 1 & 2 approval following a study involving 435 participants in that same year. At present, 35 countries and 240 cities are running 22 concurrent trials for this drug."
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