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

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020300
• Other study ID #: FF-2023-191
• Status: Recruiting
• Phase: Phase 4
• Start date: July 28, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: National University of Malaysia
• Contact: CHITHAMBARAM SETHURAMAN, MBBS
• Phone: 03-9145
• Email: chithambaramsethuraman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 31, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Drug:
• Oral Colchicine 0.6 mg
Anti-Inflammatory Effects
• Oral Pyridoxine 10 mg
Colchicine look alike placebo

Locations

Country	Name	City	State
Malaysia	Nationa University of Malaysia	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Inflammatory Effect of Colchicine	Serum Troponin I change from arrival to discharge	3-7 days
Primary	Major Adverse Cardiac Events (MACE)	Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident	3 months
Secondary	Trans thoracic Echo cardiogram parameters	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	3 months
Secondary	Safety of colchicine	Number of Participants with medication side effects	1 month