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Due to the pandemic, there were logistical issues in continuing the study.
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| Name | Class |
|---|---|
| Rawalpindi Institute of Cardiology | OTHER |
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Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection. Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease.
The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.
Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection.
Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Some anti-inflammatory agents, like pexelizumab, are focused on complement cascade.Another agent is Varespladib, which targets sPLA2 that causes oxidative stress and inflammation. There are other therapeutic targets that have been widely investigated. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease.
Colchicine binds to non-polymerized tubulin, forming a stable complex that effectively inhibits the dynamic of microtubules, depolymerizing them. Thus, any process requiring changes in the cell cytoskeleton, such as cellular mitosis, exocytosis and neutrophil motility, is affected. Colchicine has an important effect on atrial myocytes, changing the atrial response to autonomic effects (reducing the sympathetic activity and increasing the parasympathetic one). Due to this particular mode of action, colchicine has been indicated in atrial fibrillation post-cardiac surgery. A similar trial is being conducted to investigate any effusions or syndromes that occur after myocardial infarction.
The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine Group | Active Comparator | This group will receive low dose colchicine, 0.5 mg. |
|
| Placebo group | Placebo Comparator | This group will receive a placebo drug with a similar shape and mass as that to experimental drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | The tablet will be given once daily for the span of the study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular adverse events (number of events) | This outcome will be assessed using a questionnaire. The following headings will be used:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin I (ng/ml) | This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient. | 3 months |
| Creatine Kinase-Myocardial Band (IU/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nismat Javed, MBBS (2021) | Shifa College of Medicine, Shifa Tameer-e-Millat University | Principal Investigator |
| Jahanzeb Malik, MBBS (2011) | Rawalpindi Institute of Cardiology | Study Director |
| Adeel ur Rehman, MBBS, FCPS | Rawalpindi Institute of Cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rawalpindi Institute of Cardiology | Rawalpindi | 46000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20643246 | Background | Turer AT, Hill JA. Pathogenesis of myocardial ischemia-reperfusion injury and rationale for therapy. Am J Cardiol. 2010 Aug 1;106(3):360-8. doi: 10.1016/j.amjcard.2010.03.032. | |
| 23772948 | Background | Christia P, Frangogiannis NG. Targeting inflammatory pathways in myocardial infarction. Eur J Clin Invest. 2013 Sep;43(9):986-95. doi: 10.1111/eci.12118. Epub 2013 Jun 17. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo oral tablet |
| Drug |
The tablet will be given once daily for the span of the study |
|
This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient.
| 3 months |
| C-reactive protein (mg/L) | This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient. | 3 months |
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| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |