The Effect of Colchicine on Inflammation in ACS Patients

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT06054100

Collaborator

(none)

Enrollment

Location

Arms

27.6

Actual Duration (Months)

3.2

Patients Per Site Per Month

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
Acute Coronary Syndrome STEMI	Drug: Colchicine Tablets	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

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation

Primary Purpose:

Prevention

Official Title:

The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

May 20, 2022

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: Colchicine
No Intervention: STEMI standard treatment group Control group, STEMI standard treatment only

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:

Colchicine

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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