Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Periprocedural Myocardial Infarction Clinical Trial

Official title:

Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05745818
• Other study ID #: Colchicine study
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2023
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Periprocedural Myocardial Infarction
• Periprocedural Myocardial Injury
• Wounds and Injuries

Intervention

Drug:
• Colchicine Pill
oral pills

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACEs	Major Adverse Cardiac Events	one month