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Antiplatelet Agent

Colchicine + Aspirin for Cardiovascular Disease in Type 2 Diabetes (COLCOT-T2D Trial)

Phase 3
Recruiting
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cerebrovascular disease with stenosis ≥50% or prior revascularization
Diabetic retinopathy or diabetic neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to event, assessed up to 60 months
Awards & highlights

COLCOT-T2D Trial Summary

This trial looks at if colchicine & non-enteric coated aspirin help reduce cardiovascular risks for those with type 2 diabetes.

Who is the study for?
This trial is for men and women aged 55 to 80 with type 2 diabetes, without a history of significant heart disease. Participants must not be pregnant or planning pregnancy, should agree to use birth control if applicable, and cannot have severe kidney issues or be on certain medications like chronic steroids or anticoagulants.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or together, in improving heart health outcomes for those at high risk due to type 2 diabetes. It's a comparison between these drugs and their placebos.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal problems such as stomach pain or diarrhea (from colchicine), increased bleeding risk (from aspirin), allergic reactions, muscle weakness, liver issues, blood disorders but specifics will depend on individual patient responses.

COLCOT-T2D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a stroke or surgery due to severe narrowing of my brain's blood vessels.
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I have complications from diabetes affecting my eyes or nerves.
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I have had diabetes for 5 years or more.
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I am between 55 and 80 years old.
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I have never had a heart-related event due to blocked arteries.
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I cannot have children due to surgery or being postmenopausal.
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I understand and can agree to the study's procedures and risks.
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My cholesterol levels are high despite taking medication.
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My triglyceride levels are high despite taking medication for it.
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I have had surgery or treatment for blocked arteries in my legs.

COLCOT-T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to event, assessed up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to event, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Cardiovascular Death
First Event of Atrial Fibrillation
First Event of Non-fatal Myocardial Infarction
+6 more

COLCOT-T2D Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Anti-thrombotic armActive Control4 Interventions
For patients eligible for aspirin therapy arm.
Group II: Anti-inflammatory armActive Control2 Interventions
For patients ineligible for aspirin therapy arm.
Group III: Anti-thrombotic arm (Placebo)Placebo Group4 Interventions
For patients eligible for aspirin therapy arm.
Group IV: Anti-inflammatory arm (Placebo)Placebo Group2 Interventions
For patients ineligible for aspirin therapy arm.

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
58,819 Total Patients Enrolled

Media Library

Aspirin (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05633810 — Phase 3
Cardiovascular Disease Research Study Groups: Anti-thrombotic arm, Anti-thrombotic arm (Placebo), Anti-inflammatory arm, Anti-inflammatory arm (Placebo)
Cardiovascular Disease Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT05633810 — Phase 3
Aspirin (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633810 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Anti-thrombotic arm a viable option for individuals with regards to safety?

"Drawing from prior clinical data, our team at Power gave the Anti-thrombotic arm a rating of 3. This indicates that multiple rounds of research have been conducted to verify its efficacy and safety."

Answered by AI

Does this clinical trial have an age restriction for potential participants?

"The target population for this medical study is persons aged between 55 and 80 years old."

Answered by AI

Are individuals presently being enrolled in this trial?

"Per clinicaltrials.gov, this research trial is no longer recruiting patients. It was first posted on November 1st 2022 and its last update occurred on the 30th of that same month. Despite being closed to recruitment, 1261 other studies are currently open for patient enrollment."

Answered by AI

Which individuals are authorized to take part in this investigation?

"This clinical trial calls for 10,000 patients aged between fifty-five and eighty with cardiovascular conditions. Additional selection criteria includes gender, duration of diabetes, smoking status, hs-CRP levels (≥ 2mg/L), coronary calcium score (>100 Agatston Score), triglyceride levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines, LDL-C or non-HDL-C levels (4.2mmol/L+) even after the cholesterol medications are used according to protocol and Apo B ≥ 1.05 g/L)."

Answered by AI
~6667 spots leftby Dec 2027