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Coronary Artery DiseasePhase 3COL BE PCINCT06095765

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

A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Coronary Artery Disease, run by AZ Sint-Jan AV at 19 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Colchicine 0.5 MG Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,770 participants
Where
19 sitesBelgium
Study dates
29 Jan 2024to 1 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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)
  • AAA (repair, distal aortic anteroposterior diameter >3.0cm)
  • Able to be enrolled/randomized between 2 hour and 5 days post PCI.
  • Written informed consent.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

19 sites in 1 country

Belgium19 sites, 19 recruiting

  • Algemeen Stedelijk Ziekenhuis Campus Aalst

    Aalst, 9300

    An Roets

    Philippe Vanduynhoven, MD

    Recruiting

  • Het Ziekenhuisnetwerk Antwerpen

    Antwerp, 2020

    Petra Van Extergem

    Paul Vermeersch, MD, PhD

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650

    Neda Mohammadi

    Frederic De Roeck, MD

    Recruiting

  • Imelda

    Bonheiden, 2820

    Cris Vissers

    Willem Dewilde, MD, PhD

    Recruiting

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

    Sabine Creyf

    Ian Buysschaert, MD, PhD

    Recruiting

  • Humani Charleroi

    Charleroi, 6042

    Asuncion Conde y Bolado

    Adel Aminian, MD

    Recruiting

  • Grand Hôpital de Charleroi

    Charleroi, 6060

    Amandine Jourdan

    Frédéric Devroey, MD

    Not yet recruiting

  • Ziekenhuis Oost Limburg

    Genk, 3600

    Evi Theunissen

    Bert Ferdinande, MD

    Recruiting

  • AZ Sint-Lucas & Volkskliniek

    Ghent, 9000

    Nancy Deweerdt

    Kurt Hermans, MD

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Pieter Vervaet

    Frank Timmermans, MD, PhD

    Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500

    Julie Bollen

    Pascal Vranckx, MD, PhD

    Recruiting

  • Algemeen Ziekenhuis Groeninge

    Kortrijk, 8500

    Sarah Naessens

    Nick Hiltrop, MD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Karin Broos

    Peter Sinnaeve, MD, PhD

    Recruiting

  • Centre Hospitalier Regional De La Citadelle

    Liège, 4000

    Valérie Dinraths

    Charles Pirlet, MD, PhD

    Recruiting

  • Clinique Saint-Luc Bouge

    Namur, 5004

    Soon-Ja Collard

    François Simon, MD

    Recruiting

  • AZ Delta

    Roeselare, 8800

    Kathy Vervaecke

    Karl Dujardin, MD

    Recruiting

  • AZ Turnhout

    Turnhout, 2300

    Ellen Van Den Broek

    Bert Van Reet, MD

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

    Joelle De Vriese

    Shakeel Kautbally, MD

    Recruiting

  • UCL Mont-Godinne

    Yvoir, 5530

    Karine Jourdan

    Antoine Guédès, MD

    Recruiting

Other trials in Belgium

About this study

Official title: Colchicine in Belgium in Patients With Coronary Artery Disease

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.

Read the 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.

Being tested
Colchicine 0.5 MG Oral Tablet, Placebo
Keywords
percutaneous coronary intervention, colchicine
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colchicine 0.5 MG Oral TabletDrug

    Oral intake of 0.5 mg colchicine once daily

  • PlaceboDrug

    Oral intake of matching placebo once daily

Study groups in NCT06095765
Study groupRoleWhat they receive
ColchicineExperimentalColchicine 0.5 mg oral once daily, in addition to SOC
Receives: Drug: Colchicine 0.5 MG Oral Tablet
PlaceboPlacebo comparatorPlacebo oral once daily, in addition to SOC
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 44 months

Secondary outcomes (8)

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

    Time from randomisation to first occurrence of a composite of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B \& C), non-fatal stroke or coronary revascularisation

    Measured: 44 months

  2. 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

    Measured: 44 months

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

    Time from randomisation to first occurrence of: all-cause death, cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B \& C), non-fatal stroke, coronary revascularisation, ischemia driven coronary revascularisation, stent thrombosis, peripheral artery revascularisation, transient ischemic attack (TIA) treated with carotid revascularisation

    Measured: 44 months

  4. 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.

    Measured: 44 months

  5. 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

    Change from randomisation to year 1 and to end of study of participants reported outcomes:

    Seattle Angina Questionnaire (SAQ) Angina Frequency Scale: categorizes angina (chest pain) frequency as following: daily angina (score = 0-30), weekly angina (score = 31-60), monthly angina (score = 61-99), and no angina (score = 100). Higher score indicates better outcome.

    Measured: 44 months

  6. Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD): Dyspnea

    Change from randomisation to year 1 and to end of study of participants reported outcomes:

    Dyspnea (Rose Dyspnea Scale): a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4. Higher score indicates worse outcome.

    Measured: 44 months

  7. Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD): Depression.

    Change from randomisation to year 1 and to end of study of participants reported outcomes:

    Depression (Patient Health Questionnaire PHQ-2): inquires about the frequency of depressed mood and anhedonia. Scores range from 0 to 6. Higher score indicates worse outcome.

    Measured: 44 months

  8. Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD): Health-related quality of life.

    EuroQol five dimensions five level (EQ-5D-5L): consists of a descriptive system of self-perceived health status along fve dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (VAS) which provides a self-rating of the general health status on a scale from 0 (worst imaginable state of health) to 100 (best imaginable state of health).

    Measured: 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start29 Jan 2024
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Colchicine versus placebo (1:1)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06095765
Sponsor's protocol ID
ONZ-2023-0237
Other IDs
KCE-INV-21-1324, 2023-505028-74-00, 2023
Acronym
COL BE PCI
Status last verified
Mar 2024
First submitted
25 Sep 2023
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33769515

  • 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.

    PubMed 31733140

  • 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.

    PubMed 32865380

  • 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.

    PubMed 32862667

  • 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.

    PubMed 23574971

  • 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.

    PubMed 23265346

  • 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.

    PubMed 39233210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Coronary Artery Disease, run by AZ Sint-Jan AV at 19 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisette Van Hove (+32 50 45 39 07, Lisette.VanHove@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 44 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06095765, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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