Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
STEMI
About this trial
This is an interventional treatment trial for STEMI
Eligibility Criteria
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)
Sites / Locations
- Nationa University of MalaysiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colchicine Post ST Elevation Myocardial Infarction (STEMI)
Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days
Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days