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Colchicine for Coronary Artery Disease (POPCORN Trial)
POPCORN Trial Summary
This trial seeks to understand how inflammation in the heart increases risk of complications after surgery & if a medication can reduce this risk, helping reduce heart attack, stroke & death.
POPCORN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOPCORN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.POPCORN Trial Design
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Who is running the clinical trial?
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- I have a progressive muscle or nerve disease like ALS or muscular dystrophy.If I start a new medication after surgery, I understand my dose may need adjustments.My kidney function is very low or I am on dialysis.I do not have an active infection with fever or abnormal white blood cell counts.I am not taking medications like ritonavir, clarithromycin, diltiazem, or verapamil.I am having a minimally invasive surgery and have at least one heart or stroke risk factor.I have had heart surgery or have significant heart artery disease and need a major surgery soon.I have a history of severe liver disease.I have a history of inflammatory bowel disease with chronic diarrhea.I have taken colchicine or am intolerant to it within the last month.I am currently receiving therapy that affects my immune system.I have a history of myelodysplasia and currently have low blood cell counts.
- Group 1: Colchicine
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is there a current call for participants in this experiment?
"According to clinicaltrials.gov, this medical study is no longer actively recruiting participants; the listing was first posted on May 1st 2023 and most recently edited on November 15th 2022. However, there are still 571 trials seeking volunteers at present."
How many locations is this experiment taking place in?
"This clinical trial is being conducted in Long Beach, California; Dallas, Texas; Durham, North carolina and 5 other sites. Specifically this research study is based out of VA Long Beach Healthcare System in Los Angeles and the VA North Texas Health Care System Dallas Medical Center as well as the Durham VA Medical Center."
Does the Federal Drug Administration certify Colchicine for medical use?
"Backed by safety data from a Phase 4 trial, Colchicine received the highest score of 3 on our team's assessment."
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