Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
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ClinicalTrials.gov Identifier: NCT06020300 |
Recruitment Status :
Recruiting
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
STEMI | Drug: Oral Colchicine 0.6 mg Drug: Oral Pyridoxine 10 mg | Phase 4 |
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 |
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
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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
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Drug: Oral Pyridoxine 10 mg
Colchicine look alike placebo
Other Name: MSA Pyridoxine HCI 10 mg Tablet |
- Anti-Inflammatory Effect of Colchicine [ Time Frame: 3-7 days ]Serum Troponin I change from arrival to discharge
- Major Adverse Cardiac Events (MACE) [ Time Frame: 3 months ]Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
- 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
- Safety of colchicine [ Time Frame: 1 month ]Number of Participants with medication side effects
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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 |
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)
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
Contact: CHITHAMBARAM SETHURAMAN, MBBS | 03-9145 ext 8251 | chithambaramsethuraman@gmail.com | |
Contact: HAMAT HAMDI, MBBchBAO | 03-9145 ext 8251 | hamathamdi@gmail.com |
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 |
Principal Investigator: | HAMAT HAMDI, MBBchBAO | Head of Cardiology Unit |
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 |
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 |
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 |