Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
NCT ID: NCT05745818
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2023-03-01
2025-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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colchicine group
Colchicine Pill
oral pills
control group
No interventions assigned to this group
Interventions
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Colchicine Pill
oral pills
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Tarik Mahmoud Abdellah
Dr
Other Identifiers
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Colchicine study
Identifier Type: -
Identifier Source: org_study_id
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