Low dose Colchicine after Acute Myocardial Infarction: LoDoCo-MI
Low dose colchicine in survivors of an acute myocardial infarction: A pilot randomised clinical trial to establish feasibility and safety and to assess the effects on levels of inflammatory markers.
Royal Perth Hospital
210 participants
Feb 16, 2016
Interventional
Conditions
Summary
This randomised placebo-controlled trial will recruit 210 patients following an acute myocardial infarction (MI). They will be randomised to colchicine 0.5mg once daily or matching placebo for 30-days. Patients, health-care providers, data collectors and outcome adjudicators will be blinded to treatment allocation. Randomisation will occur within 7 days of the index MI and will be stratified by study centre. Baseline clinical data, including concomitant medications, serum biochemistry, full blood count and creatine kinase will be recorded. These blood tests will be repeated at 30 days. Levels of C-reactive protein (CRP) will also be measured at baseline and at 30-days. Patients with a type 1 MI (using the 3rd universal definition) will be eligible for inclusion unless they have a know contraindication to, intolerance of or clear indication for treatment with colchicine. The primary aims of this study are to provide data regarding the feasibility, tolerability and safety of low-dose colchicine after acute MI. The secondary end-points relate to the ability of colchicine to reduce CRP. Data from this trial will be used to inform the design of a larger outcome trial.
Eligibility
Inclusion Criteria2
- Patients with a type 1 myocardial infarction within the prior 7 days
- Age > 18 years.
Exclusion Criteria6
- History of myopathy, leukopenia or thrombocytopenia.
- eGFR <45ml/min per 1.73m2.
- Severe hepatic dysfunction (alanine aminotransferase >3 x ULN).
- therapy with a p-glycoprotein inhibitor (e.g. cyclosporine, verapamil or quinidine) or a strong CYP3A4 inibitor (e.g. ritonavir, clarithromycin or ketoconazole).
- Pregnancy, lactation or women of childbearing age, not using contraception.
- An indication for colchicine therapy.
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Interventions
Colchicine o.5mg once daily, oral tablet for 30 days following enrolment. Adherence will be assessed by counting returned tablets.
Locations(1)
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ACTRN12615001194550