Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Sohag University300 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Periprocedural Myocardial Infarction Periprocedural Myocardial Injury

Interventions

Colchicine PillDRUG

oral pills

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

MACEs

Major Adverse Cardiac Events

Time frame: one month

Data from ClinicalTrials.gov

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