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New treatment option for Coronary Artery Disease
Official title Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT06095765
What this study is testing
What is Colchicine 0.5 MG Oral Tablet?
Colchicine 0.5 MG Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join 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
You likely can't join if
- Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to...
- 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...
- 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...
- Creatinine clearance \<30 mL/min/1.73 m2.
See the full eligibility 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/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/assigned by chance between 2 hour and 5 days post PCI.
- Written informed consent.
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Antwerp, Belgium
- Bonheiden, Belgium
- Bruges, Belgium
- Charleroi, Belgium
- Genk, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Liège, Belgium
- Namur, Belgium
- Roeselare, Belgium
- Turnhout, Belgium
- Woluwe-Saint-Lambert, Belgium
- Yvoir, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Antwerp, Belgium; Bonheiden, Belgium; Bruges, Belgium; Charleroi, Belgium; Genk, Belgium and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.