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

Phase 4

Recruiting

• Conditions: STEMI
• Interventions: Drug: Oral Pyridoxine 10 mg; Drug: Oral Colchicine 0.6 mg

• Registration Number: NCT06020300
• Lead Sponsor: National University of Malaysia

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.

Study Timeline

• Study Start: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31
• Primary Completion: 2023-12-29
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)	Oral Pyridoxine 10 mg	Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days
Colchicine Post ST Elevation Myocardial Infarction (STEMI)	Oral Colchicine 0.6 mg	32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nationa University of Malaysia; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia