Diabete Type 2 study: Aspirin vs Colchicine
Official title COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT05633810
What this study is testing
What is Aspirin?
An investigational drug being studied for improving cardiovascular outcomes in high‑risk patients with type 2 diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether colchicine, non‑enteric aspirin, or both together can improve heart outcomes and are safe for high‑risk type 2 diabetes patients.
- Who it's for
- Adults with type 2 diabetes who are at high risk for heart problems.
- What's involved
- Participants may receive colchicine, non‑enteric aspirin, both, or a placebo, and will have regular visits and health checks.
- Time commitment
- The trial lasts several months to a few years, with scheduled clinic visits and tests throughout the study period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- Men and women aged 55 to 80 years
- Type 2 diabetes treated as per national guidelines
- No previous history of coronary artery disease-related clinical event
- Duration of diabetes of 5 years or more,
- HbA1c ≥ 8.0% or more in the last 2 years
You likely can't join if
- Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis \>30%, stroke, transient ischemic attack, or known...
- Known chronic renal insufficiency defined as an estimated glomerular filtration rate (eGFR), using the MDRD equation, of \< 35 mL/min/1.73m2
- History of cancer or lymphoproliferative disease within the last 3 years other than a successfully treated non-metastatic cutaneous squamous cell or...
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
- Peptic ulcer diagnosed within the last 24 months or previous gastro-intestinal bleeding, except for mild hemorrhoidal bleeding more than 5 years ago...
- Pre-existent progressive neuromuscular disease or known CPK level \> 3 times the upper limit of normal as measured within the past 30 days and...
See the full eligibility criteria
- Men and women aged 55 to 80 years
- Type 2 diabetes treated as per national guidelines
- No previous history of coronary artery disease-related clinical event
- Duration of diabetes of 5 years or more,
- HbA1c ≥ 8.0% or more in the last 2 years
- Active cigarette smoking,
- High hs-CRP (\> 2.0 mg/L),
- High coronary calcium score (Agatston score \>100),
- High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines,
- High LDL-C levels (≥3.5 mmol/L) or high non-HDL-C levels (≥4.2 mmol/L) despite lipid lowering therapy administered as per guidelines
- High Apo-B (≥1.05 g/L)
- Reduced HDL-C (\<1.05 mmol/L in men, \<1.3 mmol/L in women),
- Lp(a) \>50 mg/dL,
- Peripheral artery disease with stenosis ≥50% or prior revascularization,
- Cerebrovascular disease with stenosis ≥50% or prior revascularization,
- Diabetic retinopathy or diabetic neuropathy,
- Mild or moderate proteinuria (dipstick analysis) or micro-albuminuria
- Have had a hysterectomy or tubal ligation prior to baseline visit or
- Are postmenopausal defined as no menses for 12 months or a FSH level (if available) in the menopausal range.
- Patients with the capacity to provide informed consent.
- Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis \>30%, stroke, transient ischemic attack, or known heart failure
- Known chronic renal insufficiency defined as an estimated glomerular filtration rate (eGFR), using the MDRD equation, of \< 35 mL/min/1.73m2
- History of cancer or lymphoproliferative disease within the last 3 years other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix...
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
- Peptic ulcer diagnosed within the last 24 months or previous gastro-intestinal bleeding, except for mild hemorrhoidal bleeding more than 5 years ago which is permitted (patients meeting this exclusion criterion will not...
- Pre-existent progressive neuromuscular disease or known CPK level \> 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
- hemoglobin \< 100 g/L
- 2\. white blood cell count \< 3.0 X 10⁹/L
- platelet count \<110 X 10⁹/L
- ALT \> 3 times the upper limit of normal (ULN)
- total bilirubin \> 2 times ULN (unless due to Gilbert syndrome, which is allowed)
- History of cirrhosis, chronic active hepatitis or severe hepatic disease
- Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
- History of clinically significant drug or alcohol abuse in the last year
- Patient is currently using or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed, as well as replacement corticosteroids for adrenal...
- Current chronic treatment with aspirin or another antiplatelet agent (patients meeting this exclusion criterion will not be assigned by chance to receive aspirin or placebo but can be assigned by chance to receive...
- Chronic treatment with an anticoagulant agent (patients meeting this exclusion criterion will not be assigned by chance to receive aspirin or placebo but can be assigned by chance to receive colchicine or placebo)
- Current use of colchicine for other indications (mainly chronic indications consisting of Familial Mediterranean Fever or gout)
- History of an allergic reaction or significant sensitivity to colchicine
- History of an allergic reaction or significant sensitivity to aspirin (patients meeting this exclusion criterion will not be assigned by chance to receive aspirin or placebo but can be assigned by chance to receive...
- Chronic treatment with an anti-inflammatory agent (for example, anti-TNF-alpha or nonsteroidal anti-inflammatory drug (NSAID))
- Use of an investigational chemical agent less than 30 days or 5 half-lives prior to the screening visit (whichever is longer)
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Bentley, Western Australia, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Hellerup, Denmark
- Helsinki, Finland
- Luc-la-Primaube, Aveyron, France
- Vannes, Brittany Region, France
- Bezouce, Gard, France
- Vergèze, Gard, France
- Pins-Justaret, Haute-Garonne, France
- Pornic, Loire Atlantiue, France
- Poitiers, New Aquitaine, France
- Montpellier, Occitanie, France
- Toulouse, Occitanie, France
- Nîmes, Occtanie, France
- Nantes, Pays de la Loire Region, France
- Noirmoutier-en-l'Île, Pays de la Loire Region, France
- La Courneuve, Seine-Saint-Denis, France
- Poissy, Yvelines, France
- Morsang-sur-Orge, France
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bentley, Western Australia, Australia; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Hellerup, Denmark; Helsinki, Finland; Luc-la-Primaube, Aveyron, France and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.