COLCOT-T2D

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Montreal Heart Institute

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

15 Aug 2025 → ongoing

Decision date (initial)

2025-03-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Montreal Heart Institute (Founding by:Canadian Institutes of Health Research, Quebec Government)

External identifiers

EU CT number

2024-516646-19-00

ClinicalTrials.gov

NCT05633810

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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).

Secondary objectives 4

1. To determine the efficacy of study treatments on each cardiovascular (CV) event of the primary objective, and on the composite of cardiovascular death, resuscitated cardiac arrest,myocardial infarction (non-fatal) or stroke (non-fatal).
2. To evaluate the effect of study treatments on the rate of neurocognitive decline using Montreal Cognitive Assessment (MoCA) test
3. To determine the safety of long-term treatment with colchicine and aspirin, combined or alone, in this patient population.
4. For exploratory objectives please refer to the study protocol.

Conditions and MedDRA coding

Type 2 diabetic patients with no prior cardiovascular (CV) events

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Men and women aged 55 to 80 years
2. Type 2 diabetes treated as per national guidelines
3. No previous history of coronary artery disease-related clinical event
4. 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
5. 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.
6. Patients with the capacity to provide informed consent.

Exclusion criteria 19

1. Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis >30%, stroke, transient ischemic attack, or known heart failure
2. Known chronic renal insufficiency defined as an estimated glomerular filtration rate (eGFR), using the MDRD equation, of < 35 mL/min/1.73m2
3. 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
4. Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
5. 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)
6. 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
7. 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)
8. History of cirrhosis, chronic active hepatitis or severe hepatic disease
9. 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
10. History of clinically significant drug or alcohol abuse in the last year
11. 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)
12. 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)
13. 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)
14. 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
15. History of an allergic reaction or significant sensitivity to colchicine
16. 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)
17. Chronic treatment with an anti-inflammatory agent (for example, anti-TNF-alpha or nonsteroidal anti-inflammatory drug (NSAID))
18. Use of an investigational chemical agent less than 30 days or 5 half-lives prior to the screening visit (whichever is longer
19. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the time from randomization to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal), stroke (non-fatal), or urgent hospitalization for angina requiring coronary revascularization.

Secondary endpoints 5

1. Times from randomization to each component of the primary endpoint; and to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal) or stroke (non-fatal)
2. Total burden of first and subsequent primary endpoint events
3. Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit.
4. Number and proportion of patients experiencing serious adverse events.
5. For exploratory and safety end points please refer to the study protocol.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Montreal Heart Institute

Sponsor organisation

Montreal Heart Institute

Address

5000 Belanger Street

City

Montreal

Postcode

H1T 1C8

Country

Canada

Scientific contact point

Organisation

Montreal Heart Institute

Contact name

Isabelle Robert

Public contact point

Organisation

Montreal Heart Institute

Contact name

Isabelle Robert

Third parties 2

Locations

6 EU/EEA countries · 51 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 74 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications