The Effect of Colchicine on Inflammation in ACS Patients
Study Details
Study Description
Brief Summary
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Colchicine group Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months |
Drug: Colchicine Tablets
Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Other Names:
|
No Intervention: STEMI standard treatment group Control group, STEMI standard treatment only |
Outcome Measures
Primary Outcome Measures
- Effect of colchicine therapy on sST2 levels in ACS patients [3 months]
sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months
Secondary Outcome Measures
- Effect of colchicine therapy on occurrence of ischemic events in ACS patients [3 months]
Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period
- Change in left ventricular ejection fraction [3 months]
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
- Change in serum levels of IL-1beta [3 months]
Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L
- Lipid profile parameters and TG/HDL-C ratio [3 months]
Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio
Eligibility Criteria
Criteria
Inclusion Criteria:
-
male or female
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18 yrs
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STEMI patients who were successfully treated with PCI.
Exclusion Criteria:
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Pregnant or breast-feeding women or women of childbearing potential.
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Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
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Known hypersensitivity to colchicine or current chronic treatment with colchicine.
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Severe renal failure (estimated creatinine clearance <30ml/min) or hepatic failure (Child Pugh score B or C )
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Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
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Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ain shams university | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Study Director: Marwa A Ahmed, Phd, Faculty of Pharmacy, Ain Shams University
- Study Director: Lamia El Wakeel, Phd, Faculty of Pharmacy, Ain Shams University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2511