Status:
UNKNOWN
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
Lead Sponsor:
National University of Malaysia
Conditions:
STEMI
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Age between 18 years to 80 years old
- 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
- Pre-existing severe heart failure with left ventricular ejection fraction less than 35%
- Clinically unstable (Intubated or double inotropic support)
- Refuse or not suitable for cardiac revascularization therapy
- Anaemia induced Angina (Hb \< 9 g/dL)
- Ongoing sepsis requiring antibiotic
- Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 \& 7)
- Active Covid-19 Infection (\< 7 days for Category 1-3, \< 10 days for category 4-5)
- Stroke within previous 3 months
- Coronary bypass surgery either within the previous 3 years or planned
- Active malignancy or treated malignancy within 7 years
- Active Inflammatory bowel disease on treatment
- Active Neuromuscular disease on treatment
- Chronic kidney disease (CKD stage 4 - eGFR \< 30 mL/min/1.73 m2)
- Severe hepatic disease (ALT \> 3X upper limit normal, Bilirubin \> 2X upper limit normal)
- Active drug or alcohol abuse on therapy
- On long term or recent systemic glucocorticoid therapy within 3 months
- Pregnancy or breastfeeding
- Known sensitivity to colchicine or multivitamin tablet
- Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc)
- Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06020300
Start Date
July 28 2023
End Date
May 31 2024
Last Update
August 31 2023
Active Locations (1)
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1
Nationa University of Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000