COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction (NCT04420624) | Clinical Trial Compass
TerminatedPhase 2/3
COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction
Stopped: Inclusion period completed
France54 participantsStarted 2020-12-04
Plain-language summary
This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age from 18 to 80 year old
* Hospitalization within 12 hours of onset of acute chest pain
* Patient must have suffered a documented acute myocardial infarction
* Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0)
* Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty)
Exclusion Criteria:
* Patients with a history of myocardial infarction prior to the current episode
* Patient in cardiogenic shock or with hemodynamic instability
* Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min)
* Pregnant women or women of childbearing age without contraception
* Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairement
* Association with macrolides (except spiramycin)
* Association with pristinamycin
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether colchicine is still considered a viable option for protecting heart nerve function after a heart attack?
2The trial was measuring something called 'myocardial denervation' — can you explain what that means for my heart's long-term function, and why reducing it after a heart attack would matter for my recovery?
3Since this was a Phase 2/3 trial that didn't finish, how limited is the safety and effectiveness data on using colchicine this way, and are there other completed studies I should know about before considering it?
4Are there currently any active or completed trials looking at colchicine or other anti-inflammatory approaches after a heart attack that might be a better option to discuss, given that this one was terminated?
5Given that this trial didn't reach completion, would standard post-heart-attack treatment already address the nerve damage this study was trying to prevent, or is this still considered an unmet need in my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.