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Search / Trial NCT05745818

Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Launched by SOHAG UNIVERSITY · Feb 16, 2023

Trial Information

Current as of June 08, 2025

Unknown status

Keywords

Colchicine Pci Ppmi

ClinConnect Summary

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.)
2. control group of patients. Number of patients according to sample size equation.

Sample size equation i...

Gender

ALL

Eligibility criteria

  • 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.

About Sohag University

Sohag University is a distinguished academic institution located in Sohag, Egypt, committed to advancing healthcare through rigorous clinical research. As a clinical trial sponsor, the university leverages its robust infrastructure and multidisciplinary expertise to facilitate innovative studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. With a focus on ethical standards and scientific integrity, Sohag University collaborates with healthcare professionals and researchers to conduct trials that address critical health issues, ensuring the advancement of evidence-based practices in the healthcare community.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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