Clincosm LogoSign in Get a demo

Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05745818
Collaborator
(none)
300
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Colchicine Pill

Detailed Description

Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:

  1. group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour.

N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.)

  1. control group of patients. Number of patients according to sample size equation.
Sample size equation is used to calculate the minimum size of the required sample:

n = (z)2 p (1- p) / d2

  • Number of patients according to sample size equation about 300 patients 150 patient in each group of study.

  • Estimated study duration 2 years.

  • N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
colchicine group

Drug: Colchicine Pill
oral pills
control group

Outcome Measures

Primary Outcome Measures

  1. MACEs [one month]

    Major Adverse Cardiac Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  1. Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .

  2. 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).

  3. PPMI (rise in post-PCI troponin plus new evidence of ischemia).

Exclusion Criteria:

  1. Patients with active infections.

  2. Patients taking anti-inflammatory medications.

  3. Patients presented with ACS( still rising troponin).

  4. Severe renal impairment ( creatinine clearance < 45 ml/min ).

  5. Primary PCI, rescue PCI, pharmacoinvasive therapy.

  6. Connective tissue diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tarik Mahmoud Abdellah, Dr, Sohag University
ClinicalTrials.gov Identifier:
NCT05745818
Other Study ID Numbers:
  • Colchicine study
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Tarik Mahmoud Abdellah, Dr, Sohag University
Colchicine - PCI - PPMI
Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Wounds and Injuries
Colchicine

Study Results

No Results Posted as of Feb 27, 2023