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COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes

ConditionsDiabete Type 2Cardiovascular Diseases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-80
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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 and/or low-grade prostate cancer

Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea

Trial design

Design model

Factorial

Treatments tested in this trial

  • Aspirin

    Drug

    40 mg non-enteric-coated tablet taken twice daily.

  • Aspirin Placebo

    Drug

    non-enteric-coated tablet taken twice daily.

  • Colchicine

    Drug

    0.5 mg tablet taken once daily

  • Colchicine Placebo

    Drug

    tablet taken once daily.

Treatment groups

10,000 Participants
are divided into 4 treatment groups
Group A: Anti-thrombotic armActive comparator 4 interventions
Group B: Anti-thrombotic arm (Placebo)Placebo comparator 4 interventions
Group C: Anti-inflammatory armActive comparator 2 interventions
Group D: Anti-inflammatory arm (Placebo)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Cardiovascular Death

The number of participants having a cardiovascular death.

Time frame
From randomization to cardiovascular death, assessed up to 60 months.
2

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.
3

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.
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Source ClinicalTrials.gov
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