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

August 27, 2023 updated by: National University of Malaysia
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Inflammatory Effect of Colchicine
Time Frame: 3-7 days
Serum Troponin I change from arrival to discharge
3-7 days
Major Adverse Cardiac Events (MACE)
Time Frame: 3 months
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trans thoracic Echo cardiogram parameters
Time Frame: 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
3 months
Safety of colchicine
Time Frame: 1 month
Number of Participants with medication side effects
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: HAMAT HAMDI, MBBchBAO, Head of Cardiology Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Estimated)

December 29, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2023-191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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