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Study to evaluate if colchicine reduces inflammation in patients with chronic coronary artery disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Ischemic Heart Disease, which is a condition where blood flow to the heart is reduced, often due to Coronary Artery Disease. This includes people with Chronic Coronary Artery Syndrome, a long-term condition involving the narrowing of the arteries that supply blood to the heart. The research aims to determine if the medication colchicine can help lower vascular inflammation, which is the swelling or irritation of the blood vessel walls. During the study, participants will be given either colchicine or a placebo to take by mouth.

To monitor the effects of the treatment, PET/CT scans, which are specialized imaging tests that show how the body uses certain substances, will be used to look at the state of the arteries. These scans help track changes in inflammation levels within the carotid arteries, which are the main blood vessels located in the neck. The process involves comparing the level of inflammation at the beginning of the study to the level measured after six months of treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
An assessment of arterial inflammation, which is the swelling or irritation in the blood vessels, is performed using a specialized imaging scan called [¹⁸F]-FDG PET/CT.
Step 2
Medication administration
A daily dose of 1 mg of colchicine is taken by mouth for a period of 6 months.
Step 3
Final assessment
After the 6-month period of medication use, a follow-up [¹⁸F]-FDG PET/CT scan is conducted to measure changes in the carotid arteries, which are the main blood vessels in the neck.

Who can join the trial?

6 criteria

You must have stable ischemic heart disease, which means you have a long-term condition where blood flow to your heart is reduced, but your symptoms are not currently changing or worsening.
You must have had a myocardial infarction (a heart attack) or a PCI (a procedure used to open blocked heart arteries) between 1 and 12 months ago.
You must show signs of low-grade inflammation, which is a slight, ongoing swelling or irritation in the body, confirmed by a blood test showing a hs-CRP (a marker in the blood that measures inflammation) level of 2 mg/L or higher.
Your left ventricular ejection fraction (LVEF), which is a measurement of how much blood your heart pumps out with each beat, must be greater than 45%.
You must be 50 years of age or older.
You must be able to provide informed consent, which means you understand the details of the study and agree to participate.

Who cannot join the trial?

18 criteria

People who have not yet gone through menopause (the time when a woman's monthly cycles stop) or those who have had surgery to prevent pregnancy.
People with severe heart valve disease, which is a serious problem with the parts of the heart that control blood flow.
People with type 1 diabetes or type 2 diabetes that is not well controlled by medicine.
People who currently have active cancer.
People who weigh more than 130 kg.
People with inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, which are long-term problems with the digestive tract, or people with chronic diarrhea (long-lasting loose or watery stools).
People with any form of liver disease, such as cirrhosis (scarring of the liver) or chronic active hepatitis (long-term swelling of the liver).
People who are lactose intolerant, which means they have trouble digesting the sugar found in milk.
People who have had a significant problem with drug or alcohol abuse within the last year that required medical or professional help.
People with anaemia (low red blood cell levels), thrombocytopenia (low blood platelet levels), leukopenia (low white blood cell levels), liver disease, or kidney disease that has been confirmed by medical tests in the last 30 days.
Male patients who plan to try to have a baby during the study or within 6 months after the last dose.
Male patients who are having sex with women who do not wish to use contraception (methods to prevent pregnancy).
People currently using or planning to start long-term systemic steroid therapy, which means taking steroid medicines by mouth or through a vein.
People who are already taking colchicine for other reasons, such as gout (painful swelling in the joints) or familial Mediterranean fever (a type of inherited swelling disease).
People who have had an allergic reaction or a strong sensitivity to colchicine.
People with unstable angina pectoris, which is a type of chest pain that happens unpredictably and can be a sign of a serious heart problem.
People taking specific medicines that interfere with how the body processes drugs, such as amiodarone or clarithromycin, or people who eat large amounts of grapefruit.
Any person that the investigator (the doctor in charge of the study) decides is not suitable to participate for any reason.

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Herlev Hospital
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Herlev, Denmark

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Investigated drugs

Colchicine is a medication taken by mouth that is being studied to see if it can help reduce inflammation in the blood vessels of people with chronic coronary syndrome.

What is already known about the treatment

Colchicine
This medication is taken by mouth in tablet form and is an established treatment used to manage various types of inflammation. It belongs to a class of drugs known as anti-inflammatory agents and is primarily used to treat conditions like gout and certain inflammatory diseases. At a molecular level, it works by interfering with the movement of proteins within white blood cells, which helps to prevent these cells from causing excessive swelling and irritation in the body.
Placebo
This is an inactive substance taken by mouth that contains no medicinal ingredients and is used as a control in clinical studies. It is widely used in medical research to provide a baseline for comparison against active treatments. Since it has no chemical effect on the body, it serves to help researchers determine if the observed changes in a patient are actually caused by the test medication.

Investigated diseases

Coronary Artery Disease - This condition occurs when the major blood vessels that supply the heart become damaged or diseased. It is primarily caused by the buildup of fatty deposits known as plaque along the inner walls of the arteries. As these deposits grow, they can narrow the arteries and restrict the flow of oxygen-rich blood to the heart muscle. Over time, this narrowing can lead to persistent symptoms or sudden blockages. The disease is often associated with ongoing inflammation within the blood vessel walls.