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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06054100
Other study ID # 2511
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 1, 2020
Est. completion date May 20, 2022

Study information

Verified date September 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 20, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - male or female - >18 yrs - STEMI patients who were successfully treated with PCI. Exclusion Criteria: - Pregnant or breast-feeding women or women of childbearing potential. - Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents. - Known hypersensitivity to colchicine or current chronic treatment with colchicine. - Severe renal failure (estimated creatinine clearance <30ml/min) or hepatic failure (Child Pugh score B or C ) - Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction. - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Ain shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of colchicine therapy on sST2 levels in ACS patients sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months 3 months
Secondary Effect of colchicine therapy on occurrence of ischemic events in ACS patients Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period 3 months
Secondary Change in left ventricular ejection fraction Effect of colchicine therapy on left ventricular ejection fraction percentage (%) 3 months
Secondary Change in serum levels of IL-1beta Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L 3 months
Secondary Lipid profile parameters and TG/HDL-C ratio Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio 3 months
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