Effect of Colchicine on Vascular Inflammation Measured by [18F]-FDG PET/CT in Patients with Chronic Coronary Artery Syndrome: A Randomized Controlled Trial

Trial ID: 2026-525547-32-01
Sponsor: Region Hovedstaden

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Diseases & Conditions

Coronary artery disease Myocardial ischaemia

Objectives

The primary objective of this study is to evaluate the effect of colchicine on reducing vascular inflammation in patients diagnosed with chronic coronary syndrome. Inflammation levels will be quantified using [¹⁸F]-FDG PET/CT imaging to determine the impact of the intervention on underlying atherosclerosis processes.

Participants

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with chronic coronary syndrome. The cohort includes both male and female individuals within specified age ranges. Participants must present with stable ischemic heart disease, defined by a recent myocardial infarction or percutaneous coronary intervention occurring within 1 to 12 months. Inclusion requires evidence of low-grade inflammation, characterized by a high-sensitivity C-reactive protein level of 2 mg/L or greater. Additionally, a left ventricular ejection fraction greater than 45% is required. The primary objective is to assess whether colchicine reduces vascular inflammation as measured by [¹⁸F]-FDG PET/CT.

Plans and Procedures

This study is designed to evaluate the efficacy of colchicine compared to a placebo in reducing vascular inflammation. The research targets patients diagnosed with chronic coronary syndrome exhibiting evidence of low-grade inflammation. The methodology involves an assessment of changes in arterial inflammation using [¹⁸F]-FDG PET/CT imaging. The primary endpoint is defined as the change in the target-to-background ratio within the carotid arteries from baseline to the 6-month mark. Participants must meet specific inclusion criteria, including a history of stable ischemic heart disease, high-sensitivity C-reactive protein levels (hs-CRP) ≥ 2 mg/L, and a left ventricular ejection fraction greater than 45%. The clinical trial involves a screening phase to verify eligibility, followed by a treatment period and subsequent follow-up assessments. The total duration of participant involvement is expected to extend to 6 months. Early termination from the study may occur based on predefined clinical conditions or protocol deviations.

Treatment

The investigational medicinal product is colchicine. This substance is administered via the oral route at a dosage of 1 mg.

The control intervention consists of a placebo administered through the oral route with a dosage of 0 mg.

Efficacy

The efficacy of colchicine in reducing vascular inflammation will be evaluated in patients diagnosed with chronic coronary syndrome. The primary endpoint is defined as the change in arterial inflammation from baseline to 6 months.

This assessment will be performed using the target-to-background ratio (TBR) obtained via [¹⁸F]-FDG PET/CT imaging of the carotid arteries.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Patients with stable ischemic heart disease (myocardial infarction or PCI within 1–12 months), evidence of low-grade inflammation (hs-CRP ≥ 2 mg/L), left ventricular ejection fraction (LVEF) > 45%, age ≥ 50 years, and the ability to provide informed consent.

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Exclusion Criteria

Premenopausal or surgically sterile patients; patients with severe heart valve disease; patients with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus; patients with an active cancer diagnosis; patients with body weight >130 kg; patients with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea; patients with liver disease regardless of liver function tests (including a history of cirrhosis, chronic active hepatitis, or severe hepatic disease); patients with lactose intolerance; patients with a history of clinically significant drug or alcohol abuse within the past year requiring pharmacological or non-pharmacological treatment; patients with any of the following non-transient abnormalities documented within the past 30 days and confirmed on repeat testing: anaemia, thrombocytopenia, leukopenia, liver disease, or kidney disease: defined as haemoglobin <6 mmol/L, white blood cell count <3.0 × 10⁹/L, platelet count <110 × 10⁹/L, ALT >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal, or eGFR <35 mL/min; male patients planning to impregnate their partner during the study or within 6 months after the last dose; male patients having intercourse with fertile women who are unwilling to use contraception; patients currently using or planning to initiate chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids permitted); patients currently taking colchicine for other indications (e.g., familial Mediterranean fever or gout), with no wash-out required for those who discontinued colchicine prior to enrolment; patients with a history of allergic reaction or significant sensitivity to colchicine; patients with unstable angina pectoris; patients receiving potent CYP3A4 and/or P-gp inhibitors (including amiodarone, amprenavir, atazanavir, clarithromycin, diltiazem, erythromycin, telithromycin, azithromycin, fluvoxamine, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, saquinavir, nelfinavir, ritonavir, verapamil, voriconazole, pyridamole, roxithromycin, ciclosporin) or with excessive grapefruit consumption; and any patient considered by the investigator, for any reason, to be an unsuitable candidate for the study.