Using low dose colchicine after heart attacks

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

This study is testing if a low dose of colchicine can help people who have just had a heart attack feel better and improve their heart health in the long run.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: National University of Malaysia (other)
• Locations: 1 site (Kuala Lumpur, Wilayah Persekutuan)
• Trial ID: NCT06020300 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of administering oral colchicine at a low dose of 0.6 mg to patients who have experienced a ST Elevation Myocardial Infarction (STEMI) within 24 hours of admission. The approach focuses on reducing inflammation in the coronary arteries and heart muscle, which may improve both short-term and long-term outcomes for these patients. Short-term outcomes will be measured using serum troponin levels, while long-term outcomes will be assessed through transthoracic echocardiograms and monitoring for major adverse cardiac events. The study aims to provide insights into the potential benefits of colchicine in post-STEMI care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced a STEMI and are undergoing revascularization therapy.

Not a fit: Patients with severe heart failure, ongoing infections, or those not suitable for revascularization therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved recovery and reduced complications for patients after a heart attack.

How similar studies have performed: Other studies have shown promise in using anti-inflammatory treatments for heart conditions, suggesting potential for success in this approach.

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)

Where this trial is running

Kuala Lumpur, Wilayah Persekutuan

• Nationa University of Malaysia — Kuala Lumpur, Wilayah Persekutuan, Malaysia (RECRUITING)

Study contacts

• Principal investigator: HAMAT HAMDI, MBBchBAO — Head of Cardiology Unit
• Study coordinator: CHITHAMBARAM SETHURAMAN, MBBS

Conditions: STEMI