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

NCT06095765 | Recruiting Phase 3 DMC

• 3 other identifiers: ONZ-2023-0237KCE-INV-21-13242023-505028-74-00
• Study Type: interventional
• Target: 2,770
• Locations: 1 country
• Sites: 19

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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; colchicine

Outcome Measures

Primary Outcomes (1)

• Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.

  44 months

Secondary Outcomes (8)

• Time from randomisation to first occurrence of a composite of specific cardiovascular endpoints

  44 months

• Time from randomisation to first occurrence of a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke

  44 months

• Time from randomisation to first occurrence of breakdown components of primary endpoint and atherosclerosis-related diseases

  44 months

• Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.

  44 months

• Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD): Angina Frequency scale

  44 months

Other Outcomes (7)

• Change from randomisation to year 1 (and year 2 if available): in hsCRP as a measure of Inflammation.

  24 months

• Change from randomisation to year 1 (and year 2 if available): in white blood cell count as a measure of Inflammation.

  24 months

• Change from randomisation to year 1 (and year 2 if available) in total cholesterol.

  24 months

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.5 mg oral once daily, in addition to SOC

Drug: Colchicine 0.5 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo oral once daily, in addition to SOC

Drug: Placebo

Interventions

Colchicine 0.5 MG Oral Tablet DRUG

Oral intake of 0.5 mg colchicine once daily

Colchicine

Placebo DRUG

Oral intake of matching placebo once daily

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥45 years.
• Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART):
• Age ≥ year
• Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%
• Current smoking
• Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg
• Total cholesterol \>240 mg/dl untreated, or treated LDL \>70 mg/dl
• HDL \<40 mg/dl
• hsCRP \>2 mg/L AND chronic coronary syndrome (CCS)
• eGFR \<60 ml/min (MDRD)
• 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)

You may not qualify if:

• 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.
• 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.
• Any contraindication or known intolerance to colchicine.
• Chronic use of -or need for- colchicine.
• 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.).
• Creatinine clearance \<30 mL/min/1.73 m2.
• Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease
• Neuromuscular disease or non-transient CK levels \> 5 x ULN (unless due to MI).
• 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.
• 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).
• Chronic diarrhea, or inflammatory owel disease (Crohn's disease or ulcerative colitis).
• Drug or alcohol abuse.
• Planned cardiovascular intervention known on the day of screening.
• Currently enrolled in another investigational trial.
• Considered to be an unsuitable candidate by the investigator.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead
• University Hospital, Ghent: collaborator
• Belgium Health Care Knowledge Centre: collaborator

Study Sites (19)

Algemeen Stedelijk Ziekenhuis Campus Aalst

Aalst, 9300, Belgium

RECRUITING

Het Ziekenhuisnetwerk Antwerpen

Antwerp, 2020, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

RECRUITING

Imelda

Bonheiden, 2820, Belgium

RECRUITING

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

RECRUITING

Humani Charleroi

Charleroi, 6042, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, 6060, Belgium

NOT YET RECRUITING

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

RECRUITING

AZ Sint-Lucas & Volkskliniek

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Algemeen Ziekenhuis Groeninge

Kortrijk, 8500, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Centre Hospitalier Regional De La Citadelle

Liège, 4000, Belgium

RECRUITING

Clinique Saint-Luc Bouge

Namur, 5004, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

AZ Turnhout

Turnhout, 2300, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

UCL Mont-Godinne

Yvoir, 5530, Belgium

RECRUITING

Related Publications (7)

• Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.

  PMID: 33769515 BACKGROUND

• 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.

  PMID: 31733140 BACKGROUND

• Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

  PMID: 32865380 BACKGROUND

• Tong DC, Quinn S, Nasis A, Hiew C, Roberts-Thomson P, Adams H, Sriamareswaran R, Htun NM, Wilson W, Stub D, van Gaal W, Howes L, Collins N, Yong A, Bhindi R, Whitbourn R, Lee A, Hengel C, Asrress K, Freeman M, Amerena J, Wilson A, Layland J. Colchicine in Patients With Acute Coronary Syndrome: The Australian COPS Randomized Clinical Trial. Circulation. 2020 Nov 17;142(20):1890-1900. doi: 10.1161/CIRCULATIONAHA.120.050771. Epub 2020 Aug 29.

  PMID: 32862667 BACKGROUND

• Dorresteijn JA, Visseren FL, Wassink AM, Gondrie MJ, Steyerberg EW, Ridker PM, Cook NR, van der Graaf Y; SMART Study Group. Development and validation of a prediction rule for recurrent vascular events based on a cohort study of patients with arterial disease: the SMART risk score. Heart. 2013 Jun;99(12):866-72. doi: 10.1136/heartjnl-2013-303640. Epub 2013 Apr 10.

  PMID: 23574971 BACKGROUND

• 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.

  PMID: 23265346 BACKGROUND

• 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.

  PMID: 39233210 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Colchicine; Tablets

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ian Buysschaert, MD, PhD

  ian.buysschaert@azsintjan.be

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisette Van Hove

CONTACT

+32 50 45 39 07; Lisette.VanHove@azsintjan.be

Hélène De Naeyer

CONTACT

+32 9 332 05 05; helene.denaeyer@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief investigator

Model Details: Colchicine versus placebo (1:1)

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 23, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (19)