BridgeMD
COLCOT-T2D
EU CTIS ID: 2024-516646-19-00
What this study is testing
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. To assess whether low-dose colchicine on top of standard of care is effective in reducing the risk of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal), stroke (non-fatal) or urgent hospitalization for angina requiring coronary revascularization in adults with diabetes but no evident cardiovascular disease (CVD). To assess whether low-dose non-EC aspirin administered twice daily on top of standard of care is effective in reducing the risk of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal), stroke (non-fatal) or urgent hospitalization for angina requiring coronary revascularization in adults with diabetes but no evident cardiovascular disease (CVD).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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
- At least one of the following: a. Duration of diabetes of 5 years or more b. HbA1c ≥ 8.0% or more in the last 2 years c. Active cigarette smoking d. High hs-CRP (> 2.0 mg/L) e. High coronary calcium score (Agatston score >100) f. High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines g. 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 h. High Apo-B (≥1.05 g/L) i. Reduced HDL-C (<1.05 mmol/L in men, <1.3 mmol/L in women) j. Lp(a) >50 mg/dL k. Peripheral artery disease with stenosis ≥50% or prior revascularization l. Cerebrovascular disease with stenosis ≥50% or prior revascularization m. Diabetic retinopathy or diabetic neuropathy n. Mild or moderate proteinuria (dipstick analysis) or microalbuminuria
- Women of childbearing potential must have a negative urine pregnancy test at screening/randomization (visit 1) and must agree to use an effective method of birth control throughout the study.
- Patients with the capacity to provide informed consent.
You likely can't join if
- Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis >30%, stroke, transient ischemic attack, or known heart failure
- 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 insufficiency)
- Current chronic treatment with aspirin or another antiplatelet agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- Chronic treatment with an anticoagulant agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- Current use of colchicine for other indications (mainly chronic indications consisting of Familial Mediterranean Fever or gout); there is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment
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
- At least one of the following: a. Duration of diabetes of 5 years or more b. HbA1c ≥ 8.0% or more in the last 2 years c. Active cigarette smoking d. High hs-CRP (> 2.0 mg/L) e. High coronary calcium score (Agatston score >100) f. High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines g. 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 h. High Apo-B (≥1.05 g/L) i. Reduced HDL-C (<1.05 mmol/L in men, <1.3 mmol/L in women) j. Lp(a) >50 mg/dL k. Peripheral artery disease with stenosis ≥50% or prior revascularization l. Cerebrovascular disease with stenosis ≥50% or prior revascularization m. Diabetic retinopathy or diabetic neuropathy n. Mild or moderate proteinuria (dipstick analysis) or microalbuminuria
- Women of childbearing potential must have a negative urine pregnancy test at screening/randomization (visit 1) and must agree to use an effective method of birth control throughout the study.
- 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
- 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 insufficiency)
- Current chronic treatment with aspirin or another antiplatelet agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- Chronic treatment with an anticoagulant agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- Current use of colchicine for other indications (mainly chronic indications consisting of Familial Mediterranean Fever or gout); there is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment
- 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 randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- 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
- 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 and/or low-grade prostate cancer
- Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- Peptic ulcer diagnosed within the last 24 months or previous gastrointestinal bleeding, except for mild hemorrhoidal bleeding more than 5 years ago which is permitted (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
- 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
- Any of the following known parameters as measured within the past 90 days, and determined to be non-transient through repeat testing: a. hemoglobin < 100 g/L b. white blood cell count < 3.0 X 109 /L c. platelet count <110 X 109 /L d. ALT > 3 times the upper limit of normal (ULN) e. 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- New Zealand
- Canada
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; New Zealand; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.