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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001194550

Acronym

LoDoCo-MI

Enrollment

237

Registered

2015-11-04

Start date

2016-02-16

Completion date

2017-07-21

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Colchicine o.5mg once daily, oral tablet for 30 days following enrolment. Adherence will be assessed by counting returned tablets.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with a type 1 myocardial infarction within the prior 7 days Age > 18 years.

Exclusion criteria

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.

Outcome results