NCT06054100

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

February 22, 2020

Last Update Submit

September 22, 2023

Conditions

Acute Coronary SyndromeSTEMI

Keywords

ColchicineInflammationACSSTEMIAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Effect of colchicine therapy on occurrence of ischemic events in ACS patients

    3 months

  • Change in left ventricular ejection fraction

    3 months

  • Change in serum levels of IL-1beta

    3 months

  • Lipid profile parameters and TG/HDL-C ratio

    3 months

Study Arms (2)

Colchicine group

EXPERIMENTAL

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

STEMI standard treatment group

NO INTERVENTION

Control group, STEMI standard treatment only

Interventions

Colchicine TabletsDRUG

Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

Also known as: Colchicine
Colchicine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • \>18 yrs
  • STEMI patients who were successfully treated with PCI.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

Related Publications (1)

  • Hassanain HA, El Wakeel LM, Khorshid H, Ahmed MA. Colchicine effect on biomarkers of cardiac remodelling and atherosclerosis in ST-elevation myocardial infarction: A randomized controlled trial. Br J Clin Pharmacol. 2025 Feb;91(2):427-438. doi: 10.1111/bcp.16270. Epub 2024 Oct 2.

    PMID: 39359014DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial InfarctionInflammationAtherosclerosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Marwa A Ahmed, Phd

    Faculty of Pharmacy, Ain Shams University

    STUDY DIRECTOR

  • Lamia El Wakeel, Phd

    Faculty of Pharmacy, Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 22, 2020

First Posted

September 26, 2023

Study Start

February 1, 2020

Primary Completion

February 15, 2022

Study Completion

May 20, 2022

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)