Study on Colchicine for Reducing Inflammation in Patients with Stroke or TIA and Atherosclerosis

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What is this study about?

This clinical trial is focused on studying the effects of the medication Colchicine on patients who have experienced a stroke or a transient ischemic attack (TIA), which is often referred to as a “mini-stroke.” The study aims to understand if Colchicine, known for its anti-inflammatory properties, can help reduce certain markers in the blood that indicate inflammation. Inflammation in the blood vessels can increase the risk of having another stroke or heart-related issues, so reducing these markers might lower that risk.

Participants in the study will take Colchicine Tiofarma 500 microgram Tablets once daily for 30 days. The study will involve taking blood samples before and after the treatment to measure changes in inflammation markers. These markers include substances like hsCRP and IL-6, which are proteins in the blood that can indicate inflammation levels. The main goal is to see if there is a significant change in these markers after taking the medication.

The study will also look at how many participants have their hsCRP levels reduced to below a certain level by the end of the treatment. Additionally, it will monitor any side effects or reasons why participants might stop taking Colchicine. This research is important because it could provide new insights into how to prevent further strokes or heart problems in people with a history of these conditions.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as a history of ischemic stroke or transient ischemic attack (TIA), age between 18 and 90 years, and certain health conditions.

Informed consent is required to participate in the study.

2 Baseline assessment

A baseline blood test is conducted to measure serum hsCRP levels, which should be 2mg/L or higher.

Other health assessments may be performed to ensure medical stability and capability to follow study procedures.

3 Medication administration

The medication Colchicine Tiofarma 500 microgram Tablets is administered orally.

The dosage is 0.5mg daily for a duration of 30 days.

4 Monitoring and follow-up

Throughout the 30-day period, participants are monitored for any adverse effects or issues with medication tolerability.

Participants are encouraged to report any side effects experienced during the treatment.

5 Post-treatment assessment

At the end of the treatment period, a follow-up blood test is conducted to measure changes in inflammatory biomarkers, including hsCRP and IL-6.

The primary outcome is the change in these biomarkers from baseline to the end of treatment.

6 Completion of study participation

The study concludes with an analysis of the collected data to determine the effectiveness of colchicine in reducing inflammation markers.

Participants are informed of the study’s findings and any relevant health information.

Who Can Join the Study?

Must have had a prior ischemic stroke or transient ischemic attack (TIA). An ischemic stroke is when blood flow to the brain is blocked, and a TIA is a temporary blockage causing symptoms that last less than 24 hours.
Must be living at home and independent, meaning you can walk without help from another person, but you might need some help with daily activities. You should not have memory or thinking problems that limit daily activities.
Must be medically stable and able to participate in a research study, as judged by the study doctor.
Must be willing to provide informed consent, which means you agree to participate after understanding the study details.
Must be between 18 and 90 years old.
Must not have a history of chronic kidney disease, and your eGFR (a test that measures kidney function) should be greater than 50 ml/min during the screening phase.
Must have a serum hsCRP level of 2 mg/L or higher, measured within 6 months before joining the study. hsCRP is a blood test that measures inflammation in the body.
Must have a history of ischemic stroke or TIA, which is defined as a lack of blood flow to the brain, spinal cord, or retina, based on medical tests or evidence of permanent injury.
Must have atheroma, which is a buildup of fatty deposits in the arteries. This can be:
- In the arteries inside or outside the skull, causing more than 30% narrowing or blockage on the same side as the stroke.
- Near the stroke area in patients with a type of stroke called cryptogenic stroke/ESUS, where the cause is not clear, and the doctor believes no other cause is more likely.
- Have a history of ischemic heart disease (IHD) or peripheral arterial disease (PAD), or have had procedures to restore blood flow for these conditions.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with severe kidney or liver problems are excluded.
People with a known allergy to colchicine, the medication used in the study, cannot join.
Participants who have had a recent infection or surgery are not eligible.
Those currently taking certain medications that might interfere with the study drug are excluded.
Individuals with a history of certain types of cancer may not participate.
Patients with uncontrolled high blood pressure are not eligible.
People with a history of alcohol or drug abuse are excluded.
Individuals with certain heart conditions that are not stable cannot join the study.
Participants who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	31.10.2023

Trial locations

Investigated drugs:

Colchicine

Colchicine is an anti-inflammatory medication used in this clinical trial. It is being tested to see if it can lower serum biomarkers of inflammation in patients who have had a stroke or transient ischemic attack (TIA) and have evidence of atherosclerosis. The trial aims to determine if taking colchicine daily for 30 days can reduce the risk of further vascular events by decreasing inflammation in the body.

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can happen due to a blocked artery (ischemic stroke) or leaking or bursting of a blood vessel (hemorrhagic stroke). Brain cells begin to die within minutes, leading to potential loss of abilities controlled by that area of the brain. Symptoms may include trouble speaking, paralysis or numbness of the face, arm, or leg, and problems with vision or balance. The severity and effects of a stroke depend on the part of the brain affected and the extent of the damage. Recovery and rehabilitation can vary widely among individuals.

Trial ID:

2023-506967-33-00

Protocol code:

CONCISE

NCT ID:

NCT06062277

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Colchicine for Reducing Inflammation in Patients with Stroke or TIA and Atherosclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?