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Study on Colchicine and Aspirin for Improving Heart Health in Adults with Type 2 Diabetes Without Previous Heart Events

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What is this trial about?

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

This clinical trial is focused on patients with Type 2 Diabetes who have not experienced any previous cardiovascular events. The study aims to evaluate the effectiveness and safety of two medications: colchicine and non-enteric coated aspirin. These medications will be tested both individually and in combination to see if they can improve heart health outcomes in people with diabetes who are at high risk but have no apparent heart disease.

Participants in the study will receive either the active medications or a placebo. The trial will monitor the time it takes for participants to experience any major heart-related events, such as heart attacks, strokes, or the need for urgent heart procedures. The study will also track any serious side effects that may occur. The goal is to determine if adding low-dose colchicine or aspirin to standard diabetes care can reduce the risk of these heart-related issues.

The study will take place over a period of time, with regular follow-ups to assess the health of the participants. The results will help understand if these medications can provide additional protection against heart problems for people with Type 2 Diabetes who have not yet shown signs of heart disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, type 2 diabetes status, and absence of previous cardiovascular events.
A negative pregnancy test is required for women of childbearing potential, and an agreement to use effective birth control throughout the study is necessary.
Step 2
Randomization
Participants are randomly assigned to receive either the active medications or placebo tablets. This ensures that the study results are unbiased.
Step 3
Medication administration
Participants receive MIGOUTINE (colchicine) 0.5 mg in the form of a film-coated tablet, taken orally.
Participants also receive acetylsalicylic acid (non-enteric coated aspirin) in the form of a tablet, taken orally.
The frequency and duration of medication administration are determined by the study protocol and are followed throughout the trial period.
Step 4
Monitoring and follow-up
Participants are monitored for any cardiovascular events such as heart attack, stroke, or hospitalization for angina.
Regular follow-up visits are scheduled to assess the participant's health status and any changes in cognitive function using the MoCA score.
Step 5
End of study
The study is estimated to conclude by December 31, 2027.
At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of the medications in improving cardiovascular outcomes in patients with type 2 diabetes.

Who can join the trial?

19 criteria

Men and women aged between 55 and 80 years.
Have Type 2 diabetes and are being treated according to national guidelines.
No previous history of heart-related events, such as heart attacks.
Meet at least one of the following conditions:
- Have had diabetes for 5 years or more.
- Have a HbA1c level of 8.0% or more in the last 2 years. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
- Currently smoke cigarettes.
- Have a high level of hs-CRP (> 2.0 mg/L). hs-CRP is a blood test that measures inflammation in the body.
- Have a high coronary calcium score (Agatston score >100), which is a test that shows the amount of calcium in the heart's arteries.
- Have high triglyceride (TG) levels (≥1.7 mmol/L) despite taking medication to lower fats in the blood.
- Have high LDL-C levels (≥3.5 mmol/L) or high non-HDL-C levels (≥4.2 mmol/L) despite taking medication to lower fats in the blood. LDL-C and non-HDL-C are types of cholesterol in the blood.
- Have high Apo-B levels (≥1.05 g/L). Apo-B is a protein linked to cholesterol in the blood.
- Have low HDL-C levels (<1.05 mmol/L in men, <1.3 mmol/L in women). HDL-C is a type of cholesterol known as "good" cholesterol.
- Have Lp(a) levels >50 mg/dL. Lp(a) is a type of cholesterol in the blood.
- Have peripheral artery disease with a narrowing of 50% or more, or have had surgery to open blocked blood vessels.
- Have cerebrovascular disease with a narrowing of 50% or more, or have had surgery to open blocked blood vessels in the brain.
- Have diabetic retinopathy or diabetic neuropathy. These are complications of diabetes affecting the eyes and nerves.
- Have mild or moderate proteinuria or microalbuminuria, which are conditions where there is protein in the urine.
- Women who can have children must have a negative pregnancy test at the start and agree to use effective birth control during the study.
- Must be able to understand and agree to participate in the study by signing a consent form.

Who cannot join the trial?

9 criteria

Patients who have had any previous heart-related events, such as heart attacks or strokes, cannot participate.
Patients who have existing heart disease or any other cardiovascular disease are not eligible.
Patients who are not diagnosed with type 2 diabetes are excluded.
Patients who are not considered high-risk for heart problems are not eligible.
Patients who are unable to take the study medications, such as colchicine or aspirin, cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients who are under 18 years old or over 75 years old cannot participate.
Patients who have any other serious medical conditions that might interfere with the study are excluded.
Patients who are participating in another clinical trial are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Verified
Foggia, Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Responsive
Chieti, Italy

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Investigated drugs

Colchicine
is a medication used in this trial to see if it can help improve heart health in people with type 2 diabetes who are at high risk for heart problems. The study is looking at whether colchicine can reduce the chances of serious heart-related events like heart attacks, strokes, or the need for urgent heart procedures.
Aspirin
is also being tested in this trial. It is a common medication that is often used to reduce pain and inflammation. In this study, the focus is on whether taking aspirin can help prevent serious heart issues in people with type 2 diabetes who do not have obvious heart disease. The trial is examining if aspirin can lower the risk of heart-related events such as heart attacks, strokes, or the need for urgent heart procedures.

What is already known about the treatment

Colchicine
Colchicine is administered orally in tablet form. It is currently being studied for its potential benefits in improving cardiovascular outcomes in patients with type 2 diabetes who have not experienced cardiovascular events. The main therapeutic indication is to reduce the risk of cardiovascular complications such as heart attack and stroke. At the molecular level, colchicine works by inhibiting microtubule polymerization, which reduces inflammation and may help prevent cardiovascular events. It is classified as an anti-inflammatory medication.
Aspirin (non-enteric coated)
Aspirin is taken orally, typically in tablet form, and is being evaluated for its effectiveness in improving cardiovascular outcomes in high-risk patients with type 2 diabetes. The primary therapeutic indication is to lower the risk of cardiovascular events like heart attacks and strokes. Aspirin works by inhibiting the enzyme cyclooxygenase, which reduces the formation of thromboxane, a molecule that promotes platelet aggregation and blood clot formation. It is classified as an antiplatelet agent.

Investigated diseases

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops slowly, and individuals may not notice symptoms initially. As it progresses, symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision may occur. Managing blood sugar levels is crucial to prevent complications associated with this condition.