Calibrate

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Therapy

To assess whether colchicine reduces vascular inflammation, as measured by [¹⁸F]-FDG PET/CT, in patients with chronic coronary syndrome and low-grade inflammation.

Conditions and MedDRA coding

Ischemic Heart Disease, Coronary Artery Disease, Chronic Coronary Artery Syndrome

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Nordre Fasanvej 57, 1st Floor Entrance 2 1st Floor Entrance 2

City

Frederiksberg

Postcode

2000

Country

Denmark

Scientific contact point

Organisation

Region Hovedstaden

Contact name

Eva Prescott

Public contact point

Organisation

Region Hovedstaden

Contact name

Rasmus Primholdt Haahr

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications