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To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Colchicine 0.6 mg | Drug | Anti-Inflammatory Effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Safety of colchicine |
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Inclusion Criteria:
STEMI is diagnosed when there is:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHITHAMBARAM SETHURAMAN, MBBS | Contact | 03-9145 | 8251 | chithambaramsethuraman@gmail.com |
| HAMAT HAMDI, MBBchBAO | Contact | 03-9145 | 8251 | hamathamdi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| HAMAT HAMDI, MBBchBAO | Head of Cardiology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationa University of Malaysia | Recruiting | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D013607 | Tablets |
| D011736 | Pyridoxine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio
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Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
| Oral Pyridoxine 10 mg | Drug | Colchicine look alike placebo |
|
|
Number of Participants with medication side effects |
| 1 month |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D025101 |
| Vitamin B 6 |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |