Colchicine in ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction

Official Title
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Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation >1 mm in two contiguous limb leads or ST segment elevation >2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels. Excluded patients: > 80 years old with active inflammatory diseases, infectious diseases or known malignancy under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents with known hypersensitivity-allergy to colchicine under chronic treatment with colchicine with severe renal failure (eGFR < 30 ml/min/1.73 m2) with hepatic failure (Child - Pugh class B or C) presenting with cardiac arrest presenting with ventricular fibrillation presenting with cardiogenic shock with stent thrombosis with angina within 48 hours before infarction with previous myocardial infarction with occlusion of the left main or left circumflex coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission) with metallic implants (ferromagnetic material)

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients taking placebo | Drug: Placebo<br> <br> |
| Experimental: Colchicine<br>Active treatment group | Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size on MRI | MRI with LGE will be performed in a subset of study participants | 5 days post-MI | 
| AUC CK-MB concentration | Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits | 0-3 days post-MI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial damage marker levels | Maximal concentrations of hs-TnT and CK-MB | Days 1-3 post-MI |