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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06020300
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
National University of Malaysia

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : July 28, 2023
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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 Name: 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 Name: MSA Pyridoxine HCI 10 mg Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Anti-Inflammatory Effect of Colchicine [ Time Frame: 3-7 days ]
    Serum Troponin I change from arrival to discharge

  2. Major Adverse Cardiac Events (MACE) [ Time Frame: 3 months ]
    Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident


Secondary Outcome Measures :
  1. 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

  2. Safety of colchicine [ Time Frame: 1 month ]
    Number of Participants with medication side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020300


Contacts
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Contact: CHITHAMBARAM SETHURAMAN, MBBS 03-9145 ext 8251 chithambaramsethuraman@gmail.com
Contact: HAMAT HAMDI, MBBchBAO 03-9145 ext 8251 hamathamdi@gmail.com

Locations
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Malaysia
Nationa University of Malaysia Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Contact: CHITHAMBARAM SETHURAMAN, MBBS    03-9145 ext 8251    chithambaramsethuraman@gmail.com   
Contact: HAMAT HAMDI, MBBchBAO    03-9145 ext 8251    hamathamdi@gmail.com   
Sponsors and Collaborators
National University of Malaysia
Investigators
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Principal Investigator: HAMAT HAMDI, MBBchBAO Head of Cardiology Unit
More Information
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Responsible Party: National University of Malaysia
ClinicalTrials.gov Identifier: NCT06020300    
Other Study ID Numbers: FF-2023-191
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pyridoxine
Pyridoxal
Vitamin B 6
 Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs