Clinical trial NCT06020300: Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
Official title: Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: STEMI
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anti-Inflammatory Effect of Colchicine
timeFrame: 3-7 days
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 3 months
Secondary outcomes:
measure: Trans thoracic Echo cardiogram parameters
timeFrame: 3 months
measure: Safety of colchicine
timeFrame: 1 month
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Nationa University of Malaysia
state: Wilayah Persekutuan
Study officials:
affiliation: Head of Cardiology Unit
name: HAMAT HAMDI, MBBchBAO
role: PRINCIPAL_INVESTIGATOR
References: