Back to resultsThe Effect of Colchicine on Inflammation in ACS Patients
Primary Purpose
Acute Coronary Syndrome, STEMI
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Colchicine Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Colchicine, Inflammation, ACS, STEMI, Atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Ain shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Colchicine group
STEMI standard treatment group
Arm Description
Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Control group, STEMI standard treatment only
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change in left ventricular ejection fraction
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
Change in serum levels of IL-1beta
Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L
Lipid profile parameters and TG/HDL-C ratio
Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio
Full Information
NCT ID
NCT06054100
First Posted
February 22, 2020
Last Updated
September 22, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT06054100
Brief Title
The Effect of Colchicine on Inflammation in ACS Patients
Official Title
The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, STEMI
Keywords
Colchicine, Inflammation, ACS, STEMI, Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colchicine group
Arm Type
Experimental
Arm Description
Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Arm Title
STEMI standard treatment group
Arm Type
No Intervention
Arm Description
Control group, STEMI standard treatment only
Intervention Type
Drug
Intervention Name(s)
Colchicine Tablets
Other Intervention Name(s)
Colchicine
Intervention Description
Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Primary Outcome Measure Information:
Title
Effect of colchicine therapy on sST2 levels in ACS patients
Description
sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of colchicine therapy on occurrence of ischemic events in ACS patients
Description
Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period
Time Frame
3 months
Title
Change in left ventricular ejection fraction
Description
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
Time Frame
3 months
Title
Change in serum levels of IL-1beta
Description
Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L
Time Frame
3 months
Title
Lipid profile parameters and TG/HDL-C ratio
Description
Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa A Ahmed, Phd
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lamia El Wakeel, Phd
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Colchicine on Inflammation in ACS Patients
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