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

Primary Purpose

STEMI

Status
Recruiting
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Oral Colchicine 0.6 mg
Oral Pyridoxine 10 mg
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Nationa University of MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine Post ST Elevation Myocardial Infarction (STEMI)

Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)

Arm Description

32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days

Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days

Outcomes

Primary Outcome Measures

Anti-Inflammatory Effect of Colchicine
Serum Troponin I change from arrival to discharge
Major Adverse Cardiac Events (MACE)
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident

Secondary Outcome Measures

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
Safety of colchicine
Number of Participants with medication side effects

Full Information

First Posted
August 3, 2023
Last Updated
August 27, 2023
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT06020300
Brief Title
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
Official Title
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine Post ST Elevation Myocardial Infarction (STEMI)
Arm Type
Experimental
Arm Description
32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days
Arm Title
Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
Arm Type
Placebo Comparator
Arm Description
Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days
Intervention Type
Drug
Intervention Name(s)
Oral Colchicine 0.6 mg
Other Intervention Name(s)
GOUTNOR 0.6 mg Tablet
Intervention Description
Anti-Inflammatory Effects
Intervention Type
Drug
Intervention Name(s)
Oral Pyridoxine 10 mg
Other Intervention Name(s)
MSA Pyridoxine HCI 10 mg Tablet
Intervention Description
Colchicine look alike placebo
Primary Outcome Measure Information:
Title
Anti-Inflammatory Effect of Colchicine
Description
Serum Troponin I change from arrival to discharge
Time Frame
3-7 days
Title
Major Adverse Cardiac Events (MACE)
Description
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Trans thoracic Echo cardiogram parameters
Description
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
Time Frame
3 months
Title
Safety of colchicine
Description
Number of Participants with medication side effects
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHITHAMBARAM SETHURAMAN, MBBS
Phone
03-9145
Ext
8251
Email
chithambaramsethuraman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
HAMAT HAMDI, MBBchBAO
Phone
03-9145
Ext
8251
Email
hamathamdi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAMAT HAMDI, MBBchBAO
Organizational Affiliation
Head of Cardiology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationa University of Malaysia
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHITHAMBARAM SETHURAMAN, MBBS
Phone
03-9145
Ext
8251
Email
chithambaramsethuraman@gmail.com
First Name & Middle Initial & Last Name & Degree
HAMAT HAMDI, MBBchBAO
Phone
03-9145
Ext
8251
Email
hamathamdi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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