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

National University of Malaysia

Status and phase: Enrolling; Phase 4

Conditions: STEMI

Treatments: Drug: Oral Colchicine 0.6 mg; Drug: Oral Pyridoxine 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06020300

FF-2023-191

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Colchicine Post ST Elevation Myocardial Infarction (STEMI)

Experimental group

Description:

32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days

Treatment:

Drug: Oral Colchicine 0.6 mg

Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)

Placebo Comparator group

Description:

Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days

Treatment:

Drug: Oral Pyridoxine 10 mg