NCT05745818

Brief Summary

Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

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

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 16, 2023

Last Update Submit

February 16, 2023

Conditions

Periprocedural Myocardial InfarctionPeriprocedural Myocardial Injury

Keywords

Colchicine - PCI - PPMI

Outcome Measures

Primary Outcomes (1)

  • MACEs

    Major Adverse Cardiac Events

    one month

Study Arms (2)

colchicine group

Drug: Colchicine Pill

control group

Interventions

Colchicine PillDRUG

oral pills

colchicine group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

IHD patients in IMD sohag university hospital prepared for elective PCI

You may qualify if:

  • Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
  • PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
  • PPMI (rise in post-PCI troponin plus new evidence of ischemia).

You may not qualify if:

  • Patients with active infections.
  • Patients taking anti-inflammatory medications.
  • Patients presented with ACS( still rising troponin).
  • Severe renal impairment ( creatinine clearance \< 45 ml/min ).
  • Primary PCI, rescue PCI, pharmacoinvasive therapy.
  • Connective tissue diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

February 27, 2023

Record last verified: 2023-02