Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
Recruiting
Phase 3
Interventional Study
Coronary Artery Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,770 (estimated)
- Sponsor
- AZ Sint-Jan AV · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥45 years.
2. Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART):
1. Age ≥ year
2. Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%
3. Current smoking
4. Treated hyp…
Contacts