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

Sponsor

National University of Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06020300

Collaborator

(none)

Enrollment

Location

Arms

10.1

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
STEMI	Drug: Oral Colchicine 0.6 mg Drug: Oral Pyridoxine 10 mg	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratioBlock randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Tablet Pyridoxine used as placebo in view of tablet colchicine look alike

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2023

Anticipated Primary Completion Date :

Dec 29, 2023

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Oral Colchicine 0.6 mg Anti-Inflammatory Effects Other Names: GOUTNOR 0.6 mg Tablet
Placebo Comparator: 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	Drug: Oral Pyridoxine 10 mg Colchicine look alike placebo Other Names: MSA Pyridoxine HCI 10 mg Tablet

Arm

Intervention/Treatment

Experimental: 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

Drug: Oral Colchicine 0.6 mg

Anti-Inflammatory Effects

Other Names:

GOUTNOR 0.6 mg Tablet

Placebo Comparator: 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

Drug: Oral Pyridoxine 10 mg

Colchicine look alike placebo

Other Names:

MSA Pyridoxine HCI 10 mg Tablet

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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)