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

NCT05633810 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2026-03-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Aspirin

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

DRUG

Aspirin Placebo

non-enteric-coated tablet taken twice daily.

DRUG

Colchicine

0.5 mg tablet taken once daily

DRUG

Colchicine Placebo

tablet taken once daily.

Sponsors & Collaborators

  • Montreal Heart Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Australia
  • Canada
  • Denmark
  • Finland
  • France
  • Greece
  • Italy
  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633810 on ClinicalTrials.gov