Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Not yet recruiting

• Conditions: Periprocedural Myocardial Infarction; Periprocedural Myocardial Injury
• Interventions: Drug: Colchicine Pill

• Registration Number: NCT05745818
• Lead Sponsor: Sohag University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27
• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
colchicine group	Colchicine Pill	-

Primary Outcome Measures

Name	Time	Method
MACEs	one month	Major Adverse Cardiac Events