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Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention (COL BE PCI)

Primary Purpose

Coronary Artery Disease

Status

Not yet recruiting

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Colchicine 0.5 MG Oral Tablet

Placebo

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring percutaneous coronary intervention, colchicine

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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/dl 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. Exclusion Criteria: 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 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 coronary, carotid or peripheral revascularisation known on the day of screening. Currently enrolled in another investigational trial. Considered to be an unsuitable candidate by the investigator.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

Colchicine 0.5 mg oral once daily, in addition to SOC

Placebo oral once daily, in addition to SOC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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.

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.

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.

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.

Full Information

NCT ID

NCT06095765

First Posted

September 25, 2023

Last Updated

October 17, 2023

Sponsor

AZ Sint-Jan AV

Collaborators

University Hospital, Ghent, Belgium Health Care Knowledge Centre

1. Study Identification

Unique Protocol Identification Number

NCT06095765

Brief Title

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

Acronym

COL BE PCI

Official Title

Colchicine in Belgium in Patients With Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2024 (Anticipated)

Primary Completion Date

March 1, 2028 (Anticipated)

Study Completion Date

March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AZ Sint-Jan AV

Collaborators

University Hospital, Ghent, Belgium Health Care Knowledge Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

percutaneous coronary intervention, colchicine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Colchicine versus placebo (1:1)

Masking

Outcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

2770 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Experimental

Arm Description

Colchicine 0.5 mg oral once daily, in addition to SOC

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo oral once daily, in addition to SOC

Intervention Type

Drug

Intervention Name(s)

Colchicine 0.5 MG Oral Tablet

Intervention Description

Oral intake of 0.5 mg colchicine once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral intake of matching placebo once daily

Primary Outcome Measure Information:

Title

Time Frame

44 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

44 months

Title

Time Frame

44 months

Title

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

Description

Time Frame

44 months

Title

Time Frame

44 months

Title

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

Description

Time Frame

44 months

Title

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

Description

Time Frame

44 months

Title

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

Description

Time Frame

44 months

Other Pre-specified Outcome Measures:

Title

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

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: (high sensitivity) C-reactive protein (mg/dl)

Time Frame

24 months

Title

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

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: white blood cell count (/μl)

Time Frame

24 months

Title

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

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: total cholesterol (mg/dl)

Time Frame

24 months

Title

Change from randomisation to year 1 (and year 2 if available) in low density lipoprotein.

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: low density lipoprotein (LDL) (mg/dl)

Time Frame

24 months

Title

Change from randomisation to year 1 (and year 2 if available) in high density lipoprotein .

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: high density lipoprotein (HDL) (mg/dl)

Time Frame

24 months

Title

Change from randomisation to year 1 (and year 2 if available) in triglycerides.

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: triglycerides (mg/dl)

Time Frame

24 months

Title

Change from randomisation to year 1 (and year 2 if available) in kidney function.

Description

Change from randomisation to year 1 (and year 2 if available) in blood lab results from: estimated glomerular filtration rate (ml/min)

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisette Van Hove

Phone

+32 50 45 39 07

Lisette.VanHove@azsintjan.be

First Name & Middle Initial & Last Name or Official Title & Degree

Hélène De Naeyer

Phone

+32 9 332 05 05

helene.denaeyer@uzgent.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Buysschaert, MD, PhD

Organizational Affiliation

ian.buysschaert@azsintjan.be

Official's Role

Principal Investigator

Facility Information:

Facility Name

Algemeen Stedelijk Ziekenhuis Campus Aalst

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

An Roets

First Name & Middle Initial & Last Name & Degree

Philippe Vanduynhoven, MD

Facility Name

Het Ziekenhuisnetwerk Antwerpen

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Petra Van Extergem

First Name & Middle Initial & Last Name & Degree

Paul Vermeersch, MD, PhD

Facility Name

Universitair Ziekenhuis Antwerpen

City

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neda Mohammadi

First Name & Middle Initial & Last Name & Degree

Frederic De Roeck, MD

Facility Name

Imelda

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cris Vissers

First Name & Middle Initial & Last Name & Degree

Willem Dewilde, MD, PhD

Facility Name

AZ Sint-Jan Brugge-Oostende AV

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

ISPPC CHU Charleroi

City

Charleroi

ZIP/Postal Code

6042

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asuncion Conde y Bolado

First Name & Middle Initial & Last Name & Degree

Adel Aminian, MD

Facility Name

Grand Hôpital de Charleroi

City

Charleroi

ZIP/Postal Code

6060

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amandine Jourdan

First Name & Middle Initial & Last Name & Degree

Frédéric Devroey, MD

Facility Name

Ziekenhuis Oost Limburg

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

AZ Sint-Lucas & Volkskliniek

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Deweerdt

First Name & Middle Initial & Last Name & Degree

Kurt Hermans, MD

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pieter Vervaet

First Name & Middle Initial & Last Name & Degree

Frank Timmermans, MD, PhD

Facility Name

Jessa Ziekenhuis

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Algemeen Ziekenhuis Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Naessens

First Name & Middle Initial & Last Name & Degree

Nick Hiltrop, MD

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karin Broos

First Name & Middle Initial & Last Name & Degree

Peter Sinnaeve, MD, PhD

Facility Name

Centre Hospitalier Regional De La Citadelle

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valérie Dinraths

First Name & Middle Initial & Last Name & Degree

Charles Pirlet, MD, PhD

Facility Name

Clinique Saint-Luc Bouge

City

Namur

ZIP/Postal Code

5004

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soon-Ja Collard

First Name & Middle Initial & Last Name & Degree

François Simon, MD

Facility Name

AZ Delta

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathy Vervaecke

First Name & Middle Initial & Last Name & Degree

Karl Dujardin, MD

Facility Name

AZ Turnhout

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Cliniques Universitaires Saint-Luc

City

Woluwe-Saint-Lambert

ZIP/Postal Code

1200

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joelle De Vriese

First Name & Middle Initial & Last Name & Degree

Shakeel Kautbally, MD

Facility Name

UCL Mont-Godinne

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine Jourdan

First Name & Middle Initial & Last Name & Degree

Antoine Guédès, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33769515

Citation

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. Erratum In: Eur Heart J. 2021 May 23;:

Results Reference

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PubMed Identifier

31733140

Citation

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.

Results Reference

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PubMed Identifier

32865380

Citation

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.

Results Reference

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PubMed Identifier

32862667

Citation

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.

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Citation

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PubMed Identifier

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Citation

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Results Reference

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Learn more about this trial

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

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Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention (COL BE PCI)

Coronary Artery Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial