STEMI
Conditions
Brief summary
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)
Detailed description
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.
Interventions
DRUGOral Colchicine 0.6 mg
Anti-Inflammatory Effects
DRUGOral Pyridoxine 10 mg
Colchicine look alike placebo
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
Intervention model description
Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 years to 80 years old 2. 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
1. Pre-existing severe heart failure with left ventricular ejection fraction less than 35% 2. Clinically unstable (Intubated or double inotropic support) 3. Refuse or not suitable for cardiac revascularization therapy 4. Anaemia induced Angina (Hb \< 9 g/dL) 5. Ongoing sepsis requiring antibiotic 6. Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 & 7) 7. Active Covid-19 Infection (\< 7 days for Category 1-3, \< 10 days for category 4-5) 8. Stroke within previous 3 months 9. Coronary bypass surgery either within the previous 3 years or planned 10. Active malignancy or treated malignancy within 7 years 11. Active Inflammatory bowel disease on treatment 12. Active Neuromuscular disease on treatment 13. Chronic kidney disease (CKD stage 4 - eGFR \< 30 mL/min/1.73 m2) 14. Severe hepatic disease (ALT \> 3X upper limit normal, Bilirubin \> 2X upper limit normal) 15. Active drug or alcohol abuse on therapy 16. On long term or recent systemic glucocorticoid therapy within 3 months 17. Pregnancy or breastfeeding 18. Known sensitivity to colchicine or multivitamin tablet 19. Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc) 20. Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Inflammatory Effect of Colchicine | 3-7 days | Serum Troponin I change from arrival to discharge |
| Major Adverse Cardiac Events (MACE) | 3 months | Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trans thoracic Echo cardiogram parameters | 3 months | 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 |
| Safety of colchicine | 1 month | Number of Participants with medication side effects |
Countries
Malaysia
Contacts
Primary ContactCHITHAMBARAM SETHURAMAN, MBBS
Backup ContactHAMAT HAMDI, MBBchBAO
Outcome results
None listed