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

NCT06020300 | Unknown Phase 4

• 1 other identifier: FF-2023-191
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

STEMI

Outcome Measures

Primary Outcomes (2)

• Anti-Inflammatory Effect of Colchicine

  Serum Troponin I change from arrival to discharge

  3-7 days

• Major Adverse Cardiac Events (MACE)

  Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident

  3 months

Secondary Outcomes (2)

• Trans thoracic Echo cardiogram parameters

  3 months

• Safety of colchicine

  1 month

Study Arms (2)

Colchicine Post ST Elevation Myocardial Infarction (STEMI)

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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

Interventions

Oral Colchicine 0.6 mg DRUG

Anti-Inflammatory Effects

Also known as: GOUTNOR 0.6 mg Tablet

Colchicine Post ST Elevation Myocardial Infarction (STEMI)

Oral Pyridoxine 10 mg DRUG

Colchicine look alike placebo

Also known as: MSA Pyridoxine HCI 10 mg Tablet

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Nationa University of Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Colchicine; Tablets; Pyridoxine

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• HAMAT HAMDI, MBBchBAO

  Head of Cardiology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHITHAMBARAM SETHURAMAN, MBBS

CONTACT

03-9145; chithambaramsethuraman@gmail.com

HAMAT HAMDI, MBBchBAO

CONTACT

03-9145; hamathamdi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 31, 2023
• Study Start: July 28, 2023
• Primary Completion: December 29, 2023
• Study Completion: May 31, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)