Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

NCT ID: NCT06095765

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 2770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2028-03-01

Brief Summary

The main aim of this trial is to determine whether there are fewer cardiovascular events when patients with coronary artery disease take a low dose of colchicine of 0.5 mg daily on top of optimal standard treatment after treatment with PCI, compared with placebo in combination with optimal standard treatment. More specifically, we aim to investigate the benefits of a daily low dose of colchicine in patients with coronary artery disease after treatment with PCI, to confirm that a daily low dose of colchicine helps prevent additional incidents in coronary artery disease, and to identify a subgroup of patients with CAD who are at increased risk for cardiovascular events and could benefit most from colchicine.

Detailed Description

This is a prospective, randomised, double-blind, multicenter, placebo-controlled phase III pragmatic superiority trial comparing colchicine 0.5 mg with placebo administered orally once-daily in up to 2770 participants with CAD treated with PCI. Participants will be randomised in a 1:1 ratio to receive either colchicine 0.5 mg or placebo as an adjunct to standard of care. The trial is event driven with trial closure being performed when the targeted number of 566 primary endpoint events has been reached.

Participants will be seen by the site staff 1 month after randomisation and thereafter every 12 months as per standard of care (SOC) and for IMP dispense and compliance, completing questionnaires and outcome event assessment until end of study. After the first month, a telephone visit will be scheduled every 6 months in between two standard of care on-site visits.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Colchicine

Colchicine 0.5 mg oral once daily, in addition to SOC

Group Type: EXPERIMENTAL

Colchicine 0.5 MG Oral Tablet

Intervention Type: DRUG

Oral intake of 0.5 mg colchicine once daily

Placebo

Placebo oral once daily, in addition to SOC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral intake of matching placebo once daily

Interventions

Colchicine 0.5 MG Oral Tablet

Oral intake of 0.5 mg colchicine once daily

Intervention Type: DRUG

Placebo

Oral intake of matching placebo once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥45 years.

2. Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART):

1. Age ≥ year

2. Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%

3. Current smoking

4. Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg

5. Total cholesterol >240 mg/dl untreated, or treated LDL >70 mg/dl

6. HDL <40 mg/dl

7. hsCRP >2 mg/L AND chronic coronary syndrome (CCS)

8. eGFR <60 ml/min (MDRD)

9. history of vascular disease:

• CAD (PCI prior to index, CABG, MI)
• stroke (ischemic or hemorrhagic)
• carotid artery revascularisation
• PAD (revascularisation, ABI <0.85 at rest, amputation due to atherosclerotic disease)
• AAA (repair, distal aortic anteroposterior diameter >3.0cm)

3. Able to be enrolled/randomized between 2 hour and 5 days post PCI.

4. Written informed consent.

Exclusion Criteria

1. Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to donate oocytes.

2. Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. Or men who intend to donate sperm.

3. Any contraindication or known intolerance to colchicine.

4. Chronic use of -or need for- colchicine.

5. Auto-immune disease or other condition requiring current or planned chronic systemic steroids, immunosuppressant or biologic drug targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab etc.).

6. Creatinine clearance <30 mL/min/1.73 m2.

7. Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease

8. Neuromuscular disease or non-transient CK levels > 5 x ULN (unless due to MI).

9. History of cancer or lymphoproliferative disease within the last 3 years, other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, or localized cervix carcinoma in situ.

10. Current or planned use of any strong inhibitor of CYP3A4 or p-glycoprotein: macrolide antibiotics (clarithromycin, telithromycin), azole antifungal agents (ketoconazole, voriconazole, fluconazole, itraconazole), cyclosporine, HIV medication (ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir).

11. Chronic diarrhea, or inflammatory owel disease (Crohn's disease or ulcerative colitis).

12. Drug or alcohol abuse.

13. Planned cardiovascular intervention known on the day of screening.

14. Currently enrolled in another investigational trial.

15. Considered to be an unsuitable candidate by the investigator.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

Sponsor Role: collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Ian Buysschaert, MD PhD

MD, PhD, Chief investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Buysschaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ian.buysschaert@azsintjan.be

Locations

Algemeen Stedelijk Ziekenhuis Campus Aalst

Aalst, , Belgium

Site Status: RECRUITING

Het Ziekenhuisnetwerk Antwerpen

Antwerp, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status: RECRUITING

Imelda

Bonheiden, , Belgium

Site Status: RECRUITING

AZ Sint-Jan Brugge-Oostende AV

Bruges, , Belgium

Site Status: RECRUITING

Humani Charleroi

Charleroi, , Belgium

Site Status: RECRUITING

Grand Hôpital de Charleroi

Charleroi, , Belgium

Site Status: NOT_YET_RECRUITING

Ziekenhuis Oost Limburg

Genk, , Belgium

Site Status: RECRUITING

AZ Sint-Lucas & Volkskliniek

Ghent, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status: RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status: RECRUITING

Algemeen Ziekenhuis Groeninge

Kortrijk, , Belgium

Site Status: RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Centre Hospitalier Regional De La Citadelle

Liège, , Belgium

Site Status: RECRUITING

Clinique Saint-Luc Bouge

Namur, , Belgium

Site Status: RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status: RECRUITING

AZ Turnhout

Turnhout, , Belgium

Site Status: RECRUITING

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, , Belgium

Site Status: RECRUITING

UCL Mont-Godinne

Yvoir, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lisette Van Hove

Role: CONTACT

Lisette.VanHove@azsintjan.be

+32 50 45 39 07

Hélène De Naeyer

Role: CONTACT

helene.denaeyer@uzgent.be

+32 9 332 05 05

Facility Contacts

An Roets

Role: primary

Petra Van Extergem

Role: primary

Neda Mohammadi

Role: primary

Cris Vissers

Role: primary

Sabine Creyf

Role: primary

Asuncion Conde y Bolado

Role: primary

Amandine Jourdan

Role: primary

Evi Theunissen

Role: primary

Nancy Deweerdt

Role: primary

Pieter Vervaet

Role: primary

Julie Bollen

Role: primary

Sarah Naessens

Role: primary

Karin Broos

Role: primary

Valérie Dinraths

Role: primary

Soon-Ja Collard

Role: primary

Kathy Vervaecke

Role: primary

Ellen Van Den Broek

Role: primary

Joelle De Vriese

Role: primary

Karine Jourdan

Role: primary

References

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Reference Type: BACKGROUND

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Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

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Reference Type: BACKGROUND

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Nidorf SM, Eikelboom JW, Budgeon CA, Thompson PL. Low-dose colchicine for secondary prevention of cardiovascular disease. J Am Coll Cardiol. 2013 Jan 29;61(4):404-410. doi: 10.1016/j.jacc.2012.10.027. Epub 2012 Dec 19.

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De Cock E, Kautbally S, Timmermans F, Bogaerts K, Hanet C, Desmet W, Gurne O, Vranckx P, Hiltrop N, Dujardin K, Vanduynhoven P, Vermeersch P, Pirlet C, Hermans K, Van Reet B, Ferdinande B, Aminian A, Dewilde W, Guedes A, Simon F, De Roeck F, De Vroey F, Jukema JW, Sinnaeve P, Buysschaert I. Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial. Am Heart J. 2024 Dec;278:61-71. doi: 10.1016/j.ahj.2024.08.022. Epub 2024 Sep 2.

Reference Type: DERIVED

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Other Identifiers

KCE-INV-21-1324

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-505028-74-00

Identifier Type: OTHER

Identifier Source: secondary_id

ONZ-2023-0237

Identifier Type: -

Identifier Source: org_study_id