Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)

Study Overview
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Brief Summary
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To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)

Detailed Description
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Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial infarction which may benefit in short and long term outcome in patients. The short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.

Official Title
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Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)

Conditions
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STEMI

Intervention / Treatment
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* Drug: Oral Colchicine 0.6 mg
* Drug: Oral Pyridoxine 10 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 years to 80 years old STEMI within 24 hours of admission to Pusat Perubatan UKM & undergoing revascularization therapy (percutaneous coronary intervention) during admission STEMI is diagnosed when there is: ST elevation of ≥1 mm in 2 contiguous leads or a new onset LBBB in the resting ECG in a patient with ischaemic type chest pains of > 30 minutes and accompanied by a rise and fall in cardiac biomarkers (CPG MALAYSIA STEMI 2019, 4th Edition) Exclusion Criteria: Pre-existing severe heart failure with left ventricular ejection fraction less than 35% Clinically unstable (Intubated or double inotropic support) Refuse or not suitable for cardiac revascularization therapy Anaemia induced Angina (Hb < 9 g/dL) Ongoing sepsis requiring antibiotic Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 & 7) Active Covid-19 Infection (< 7 days for Category 1-3, < 10 days for category 4-5) Stroke within previous 3 months Coronary bypass surgery either within the previous 3 years or planned Active malignancy or treated malignancy within 7 years Active Inflammatory bowel disease on treatment Active Neuromuscular disease on treatment Chronic kidney disease (CKD stage 4 - eGFR < 30 mL/min/1.73 m2) Severe hepatic disease (ALT > 3X upper limit normal, Bilirubin > 2X upper limit normal) Active drug or alcohol abuse on therapy On long term or recent systemic glucocorticoid therapy within 3 months Pregnancy or breastfeeding Known sensitivity to colchicine or multivitamin tablet Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc) Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)

Ages Eligible for Study
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Minimum Age: 18 Years
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
Interventional Model Description: Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine Post ST Elevation Myocardial Infarction (STEMI)<br>32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days | Drug: Oral Colchicine 0.6 mg<br>* Anti-Inflammatory Effects<br>* Other names: GOUTNOR 0.6 mg Tablet;|
| Placebo Comparator: Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)<br>Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days | Drug: Oral Pyridoxine 10 mg<br>* Colchicine look alike placebo<br>* Other names: MSA Pyridoxine HCI 10 mg Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Inflammatory Effect of Colchicine | Serum Troponin I change from arrival to discharge | 3-7 days | 
| Major Adverse Cardiac Events (MACE) | Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans thoracic Echo cardiogram parameters | Left ventricular ejection fraction (biplane mode) measured in %, left ventricular volume measured in milliliters, left atrial volume measured in milliliters, E/A ratio, E/e ' ratio | 3 months | 
| Safety of colchicine | Number of Participants with medication side effects | 1 month |