What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease, such as colchicine and non-enteric coated aspirin, have notable side effects. Colchicine can cause gastrointestinal disturbances (diarrhea, nausea, vomiting), myopathy, and bone marrow suppression. Non-enteric coated aspirin is associated with gastrointestinal bleeding, peptic ulcers, increased bleeding risk, allergic reactions, and can worsen asthma. Patients should discuss these potential side effects with their healthcare provider to manage risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cardiovascular disease that are similar to colchicine and non-enteric coated aspirin. Colchicine, which reduces inflammation by inhibiting microtubule polymerization, has been studied for its potential benefits in cardiovascular conditions, particularly in reducing the risk of recurrent pericarditis and post-myocardial infarction complications. Non-enteric coated aspirin, which inhibits cyclooxygenase to reduce platelet aggregation, has long been approved for the prevention of myocardial infarction and stroke in high-risk patients. Other related FDA-approved antiplatelet drugs include clopidogrel and ticagrelor, which also aim to prevent clot formation and improve cardiovascular outcomes.

What other types of research exist?

Promising novel alternatives for cardiovascular disease treatment in 2024 include PCSK9 inhibitors (e.g., evolocumab, alirocumab) which lower LDL cholesterol levels, and SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) which have shown cardiovascular benefits in patients with diabetes. Additionally, anti-inflammatory agents like canakinumab, an IL-1β inhibitor, have shown potential in reducing cardiovascular events by targeting inflammation.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to event, assessed up to 60 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing colchicine and non-coated aspirin, alone or together, to help high-risk type 2 diabetes patients avoid heart problems. Colchicine reduces inflammation, and aspirin helps prevent blood clots.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to event, assessed up to 60 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Cardiovascular Death

First Event of Atrial Fibrillation

First Event of Non-fatal Myocardial Infarction

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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-inflammatory arm (Placebo)Placebo Group2 Interventions

For patients ineligible for aspirin therapy arm.

Group IV: Anti-thrombotic arm (Placebo)Placebo Group4 Interventions

For patients eligible for aspirin therapy arm.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiovascular disease often target inflammation and platelet aggregation, both of which are critical in the progression of the disease. Colchicine inhibits microtubule polymerization, reducing inflammation, while non-enteric coated aspirin inhibits cyclooxygenase, decreasing platelet aggregation and preventing thrombus formation. These mechanisms are essential as they help lower the risk of cardiovascular events like heart attacks and strokes by addressing two major contributing factors: inflammation and clot formation.

Influence of Vincristine, Clinically Used in Cancer Therapy and Immune Thrombocytopenia, on the Function of Human Platelets.High dose intravenous aspirin, not low dose intravenous or oral aspirin, inhibits thrombus formation and stabilizes blood flow in experimental coronary vascular injury.Effect of colchicine compared with placebo on high sensitivity C-reactive protein in patients with acute coronary syndrome or acute stroke: a pilot randomized controlled trial.