CALIBRATE
Key facts
- Where
- Frederiksberg, DániaSee the site
- Phase
- 4. fázis
Where in Dánia
- Region HovedstadenFrederiksberg, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2026-525547-32-01
- Record updated
- 2026. május 6.
- Original description
To assess whether colchicine reduces vascular inflammation, as measured by [¹⁸F]-FDG PET/CT, in patients with chronic coronary syndrome and low-grade inflammation.Read full original descriptionShow less
Colchicine Assessment of Low-grade Inflammation and Biomarker Response in Atherosclerosis with Targeted Evaluation
To assess whether colchicine reduces vascular inflammation, as measured by [¹⁸F]-FDG PET/CT, in patients with chronic coronary syndrome and low-grade inflammation.
Inclusion: 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: 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.