Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05745818
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: