COLCHICINE for Ischemic heart disease | Coronary artery disease | Chronic coronary syndrome

Inclusion criteria

• {"criterion_text":"-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."}

Exclusion criteria

• {"criterion_text":"-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."}

Primary endpoints

• {"endpoint_text":"-The primary endpoint is the change in arterial inflammation from baseline to 6 months, assessed by target-to-background ratio (TBR) of [¹⁸F]-FDG PET/CT in the carotid arteries.","definition_or_measurement_approach":"Change from baseline to 6 months measured by target-to-background ratio (TBR) on [¹⁸F]-FDG PET/CT of the carotid arteries."}

Denmark

Earliest CTIS Part Ii Submission Date

21-04-2026

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}