Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
NCT ID: NCT06020300
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
64 participants
INTERVENTIONAL
2023-07-28
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Colchicine Post ST Elevation Myocardial Infarction (STEMI)
32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days
Oral Colchicine 0.6 mg
Anti-Inflammatory Effects
Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days
Oral Pyridoxine 10 mg
Colchicine look alike placebo
Interventions
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Oral Colchicine 0.6 mg
Anti-Inflammatory Effects
Oral Pyridoxine 10 mg
Colchicine look alike placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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National University of Malaysia
OTHER
Responsible Party
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Principal Investigators
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HAMAT HAMDI, MBBchBAO
Role: PRINCIPAL_INVESTIGATOR
Head of Cardiology Unit
Locations
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Nationa University of Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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CHITHAMBARAM SETHURAMAN, MBBS
Role: primary
HAMAT HAMDI, MBBchBAO
Role: backup
Other Identifiers
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FF-2023-191
Identifier Type: -
Identifier Source: org_study_id