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The Effect of Colchicine on Inflammation in ACS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06054100
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Hanan ahmed, Ain Shams University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2020
Actual Primary Completion Date : February 15, 2022
Actual Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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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 Name: Colchicine
No Intervention: STEMI standard treatment group
Control group, STEMI standard treatment only


Outcome Measures
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Primary Outcome Measures :
  1. Effect of colchicine therapy on sST2 levels in ACS patients [ Time Frame: 3 months ]
    sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months


Secondary Outcome Measures :
  1. Effect of colchicine therapy on occurrence of ischemic events in ACS patients [ Time Frame: 3 months ]
    Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period

  2. Change in left ventricular ejection fraction [ Time Frame: 3 months ]
    Effect of colchicine therapy on left ventricular ejection fraction percentage (%)

  3. Change in serum levels of IL-1beta [ Time Frame: 3 months ]
    Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L

  4. Lipid profile parameters and TG/HDL-C ratio [ Time Frame: 3 months ]
    Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054100


Locations
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Egypt
Ain shams university
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Marwa A Ahmed, Phd Faculty of Pharmacy, Ain Shams University
Study Director: Lamia El Wakeel, Phd Faculty of Pharmacy, Ain Shams University
More Information
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Responsible Party: Hanan ahmed, Principle investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT06054100    
Other Study ID Numbers: 2511
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hanan ahmed, Ain Shams University:
Colchicine
Inflammation
ACS
STEMI
Atherosclerosis
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents