A Phase 3 interventional study of Aspirin and Aspirin Placebo in Diabete Type 2 and Cardiovascular Diseases, sponsored by Montreal Heart Institute. Recruiting at 39 sites in 8 countries. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Montreal Heart Institute · Phase 3, Interventional, and Prevention
Among 414 studies in Diabetes Mellitus, Type 2 with a site in France — 36 open to participants now, 42 under way, 9 of them phase 3. Diabetes Mellitus, Type 2 · France.
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, this one is the 8th largest by planned enrollment of the 336 interventional ones that give a count, is one of 20 that started in 2022, is one of 139 in phase 3, reaches primary completion later than 18 of the 41 other live ones, and was the 375th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →36 of the 414 studies in Diabetes Mellitus, Type 2 with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 55 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →414 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 20 started in 2022.
Median enrollment 312 across the 336 interventional studies, 276 across the 78 observational. Of the 335 that completed or were terminated, 132 (39%) have results posted.
234 of 414 have an industry lead sponsor. The 10 most frequent:
Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 24 are open to participants now.
Montreal Heart Institute has 6 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus, Type 2 with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05882071Boehringer IngelheimNon-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France | 2026-11-30 |
| NCT06579404University of CambridgeClosed-loop in Adults With Type 2 Diabetes | 2027-03 |
| NCT06567990Hospices Civils de LyonType 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes | 2027-05-25 |
| NCT06614101University Hospital, ToulouseStudy Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air | 2027-05-31 |
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, from their registry updates:
To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
And at least one of the following:
Women of must have a negative urine pregnancy test at screening/randomization visit 1 and must agree to use an effective method of throughout the study. Acceptable means of birth control include: oral contraceptives, implantable contraceptives, injectable contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner.
Women are considered not of childbearing potential if they either:
Exclusion Criteria:
Any of the following known parameters as measured within the past 90 days, and determined to be non-transient through repeat testing:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For patients eligible for aspirin therapy arm.
Drug: Aspirin · Drug: Aspirin Placebo · Drug: Colchicine · Drug: Colchicine Placebo
For patients eligible for aspirin therapy arm.
Drug: Aspirin · Drug: Aspirin Placebo · Drug: Colchicine · Drug: Colchicine Placebo
For patients ineligible for aspirin therapy arm.
Drug: Colchicine · Drug: Colchicine Placebo
For patients ineligible for aspirin therapy arm.
Drug: Colchicine · Drug: Colchicine Placebo
40 mg non-enteric-coated tablet taken twice daily.
non-enteric-coated tablet taken twice daily.
0.5 mg tablet taken once daily
tablet taken once daily.
First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization.
The number of participants having at least one of the composite of the primary endpoint.
Time frame: From randomization to occurrence of first event, assessed up to 60 months.
Cardiovascular Death
The number of participants having a cardiovascular death.
Time frame: From randomization to cardiovascular death, assessed up to 60 months.
First Event of Resuscitated Cardiac Arrest
The number of participants having at least 1 resuscitated cardiac arrest.
Time frame: From randomization to event, assessed up to 60 months.
First Event of Non-fatal Myocardial Infarction
The number of participants having at least 1 myocardial infarction.
Time frame: From randomization to event, assessed up to 60 months.
First Event of Non-fatal Stroke
The number of participants having at least 1 stroke.
Time frame: From randomization to event, assessed up to 60 months
First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization
The number of participants having at least 1 urgent hospitalization for angina requiring coronary revascularization.
Time frame: From randomization to occurrence, assessed up to 60 months.
First Event of Atrial Fibrillation
The number of participants having at least 1 atrial fibrillation.
Time frame: From randomization to event, assessed up to 60 months.
First Occurrence of Heart Failure Hospitalization
The number of participants having at least 1 heart failure hospitalization.
Time frame: From randomization to occurrence, assessed up to 60 months.
First Occurrence of Coronary Revascularization
The number of participants having at least 1 coronary revascularization.
Time frame: From randomization to occurrence, assessed up to 60 months.
MoCA Scores Assessed Over Time
Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit.
Time frame: From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Dec 2027, 60 months after the start.
Of 87 non-industry phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 60 months is above that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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