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 study about?

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.

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.

2 randomization

Participants are randomly assigned to receive either the active medications or placebo tablets. This ensures that the study results are unbiased.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Ente Ecclesiastico Ospedale Generale Regionale Miulli Acquaviva Delle Fonti Italy
Centre Hospitalier De Beziers Beziers France
Maison de santé – Au Fil de l’Eau. Pantin France
Cabinet Médical les Oiseaux Morsang-sur-Orge France
MSPU Pins Justaret Pins Justaret France
Association Pour Le Developpement Des Centres De Sante Toulouse France
MSPU la Source Vergèze France
Azienda Sanitaria Regionale del Molise (ASREM) Campobasso Italy
Maison de santé pluriprofessionnelle universitaire Jacques Prévert Montigny le Bretonneux France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Fondazione Toscana Gabriele Monasterio Pisa Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Clinique Du Pont De Chaume Montauban France
Azienda Sanitaria Locale 5 Spezzino La Spezia Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Da Luz S.A. Lisbon Portugal
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda USL Toscana Centro Prato Italy
Azienda Sanitaria Locale Citta Di Torino Turin Italy
Evgenidion Clinic Agia Trias S.A. Athens Greece
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Gentofte Hospital Hellerup Denmark
Universita’ Degli Studi Di Ferrara Ferrara Italy
Association Pour Le Developpement Des Centres De Sante – Kersanté Paris France
Centre Hospitalier De Pau Pau France
De Joze SISA Joze France
Du Pole De Sante Du Port De Granville SISA Granville France
Mjvrqd di Spwuw Pcqslulgzxcfcxbchebl Oxie Bezouces France
Mwshlt dn Svgtn Lw Cuhnnrzwgg Poissy France
Ckxxki Mujuccdgu dh Sujoy &uxqjlk Li Cazwsnicp La Courneuve France
Cnyvly Myxfkvu Vijmf Rkuva Montpellier France
Mahbzr dj saksp prziwmchergcfhhzeu &ohbpqy Lxo Lm Pblfgecj Luc-La-Primaube France
Mapqwy db Sytql Pmpusmkpdfocmxkzoc Uhcqhlltgxdhl Ly Plfxdoqhkr Toulouse France
Hvxxuvuz Umzhdurmdv Coodvhp Hykzqknx Helsinki Finland
Cezrlt Hcezayoxzom De Cpbvneqoxak Carcassonne France
Aijgczx Outrykfjjnf Uvnyrpvvakyhy Okkblnoa Rwcqnnu Foggia Italy
Cbnstdg Mtjvtnt db Dh Msubpc Pontgibaud France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.01.2025
Finland Finland
Recruiting
01.01.2025
France France
Recruiting
01.01.2025
Greece Greece
Recruiting
01.01.2025
Italy Italy
Recruiting
01.01.2025
Portugal Portugal
Recruiting
01.01.2025

Trial locations

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.

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.

Trial ID:
2024-516646-19-00
Protocol code:
MHICC-2021-001
NCT ID:
NCT05633810
Trial Phase:
Therapeutic confirmatory (Phase III)

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