RecruitingPhase 2Phase 3ACTRN12610000397011

LoDoCo - VRIC Low Dose Colchicine in stable coronary artery disease, Vascular Reactivity and the Inflammatory Cascade.

The effect of low dose colchicine(1mg/dy) administered to patients with stable coronary artery disease compared with no treatment on brachial artery flow mediated dilation and blood inflammatory markers.


Sponsor

Pfizer Cardiovascular Lipid Research Grant

Enrollment

40 participants

Start Date

Jan 1, 2010

Study Type

Interventional

Conditions

Summary

The LoDoCo VRIC study aims to investigate the effect of low dose colchicine on inflammatory markers and coronary artery disease as measured by a surrogate marker, brachial artery flow mediated dilation in a stable coronary artery disease population.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose colchicine — a medication usually used for gout — can reduce inflammation and improve blood vessel function in people with stable coronary artery disease (heart disease). Inflammation plays a key role in the buildup of plaques in heart arteries, and colchicine may help by calming this inflammation. Researchers will measure blood vessel flexibility and inflammatory markers in the blood. You may be eligible if: - You are between 18 and 80 years old - You have confirmed coronary artery disease (proven by angiogram showing significant blockage, or you have had a stent procedure) - Your condition has been stable for at least 1 month - You have no contraindications to colchicine You may NOT be eligible if: - Your coronary artery disease is not stable, or only mild - You have advanced heart failure (NYHA grade 3 or 4) - You have severe kidney disease or known cancer - You have inflammatory bowel disease - You are taking cyclosporine or other medications that interact with colchicine - You are pregnant or planning to become pregnant during the study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients are randomly assigned to treatment or control group initially and then cross over to the alternate group after a one month washout period. Colchicine 1mg/day oral tablets for three months

Patients are randomly assigned to treatment or control group initially and then cross over to the alternate group after a one month washout period. Colchicine 1mg/day oral tablets for three months on top of standard medical therapy will be administered while in the treatment group. Standard medical therapy will include any of the following and is at the discretion of the primary care physician: Statins, Angiotensin Converting Enzyme inhibitors, Beta Blockers and Aspirin. Flow mediated dilation testing is performed at baseline and after three months participation in both control and treatment arms.


Locations(1)

Australia

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