Actively Recruiting
Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
Led by AZ Sint-Jan AV · Updated on 2024-03-08
2770
Participants Needed
19
Research Sites
213 weeks
Total Duration
On this page
Sponsors
A
AZ Sint-Jan AV
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older
- Diagnosed with coronary artery disease treated with PCI and optimal medical therapy
- Have at least one additional risk factor such as diabetes, current smoking, treated hypertension, high cholesterol, low HDL, elevated hsCRP with chronic coronary syndrome, reduced kidney function, or history of vascular disease
- Able to be enrolled and randomized between 2 hours and 5 days after PCI
- Provide written informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or of childbearing potential not using effective contraception, or who intend to donate oocytes
- Men who plan to father children during the study or are unwilling to use contraception, or who intend to donate sperm
- Known intolerance or contraindication to colchicine
- Chronic use of or need for colchicine
- Autoimmune diseases or conditions requiring chronic systemic steroids, immunosuppressants, or biologic immune-targeting drugs
- Creatinine clearance below 30 mL/min/1.73 m²
- Cirrhosis Child-Pugh stage B or C, or acute severe liver disease
- Neuromuscular disease or persistent high creatine kinase levels unless due to heart attack
- History of cancer or lymphoproliferative disease within the last 3 years except certain treated skin or cervical cancers
- Current or planned use of strong CYP3A4 or p-glycoprotein inhibitors
- Chronic diarrhea or inflammatory bowel disease
- Drug or alcohol abuse
- Planned cardiovascular intervention known at screening
- Currently enrolled in another investigational trial
- Considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Algemeen Stedelijk Ziekenhuis Campus Aalst
Aalst, Belgium, 9300
Actively Recruiting
2
Het Ziekenhuisnetwerk Antwerpen
Antwerp, Belgium, 2020
Actively Recruiting
3
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
Actively Recruiting
4
Imelda
Bonheiden, Belgium, 2820
Actively Recruiting
5
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium, 8000
Actively Recruiting
6
Humani Charleroi
Charleroi, Belgium, 6042
Actively Recruiting
7
Grand Hôpital de Charleroi
Charleroi, Belgium, 6060
Not Yet Recruiting
8
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Actively Recruiting
9
AZ Sint-Lucas & Volkskliniek
Ghent, Belgium, 9000
Actively Recruiting
10
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
11
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
12
Algemeen Ziekenhuis Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
13
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
14
Centre Hospitalier Regional De La Citadelle
Liège, Belgium, 4000
Actively Recruiting
15
Clinique Saint-Luc Bouge
Namur, Belgium, 5004
Actively Recruiting
16
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
17
AZ Turnhout
Turnhout, Belgium, 2300
Actively Recruiting
18
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium, 1200
Actively Recruiting
19
UCL Mont-Godinne
Yvoir, Belgium, 5530
Actively Recruiting
Research Team
L
Lisette Van Hove
CONTACT
H
Hélène De Naeyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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