Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05745818

Enrollment

300

Registered

2023-02-27

Start date

2023-03-01

Completion date

2025-03-01

Last updated

2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprocedural Myocardial Infarction, Periprocedural Myocardial Injury

Keywords

Colchicine - PCI - PPMI

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.

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.) 2. 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.

Interventions

DRUGColchicine Pill

oral pills

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
MACEs	one month	Major Adverse Cardiac Events

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026