Determining the effect of Colchicine on reducing myocardial damage caused by coronary angioplasty procedure in patients with coronary artery disease referred to Shahid Madani Hospital in Khorramabad in 2023
Design
This study is a clinical trial study with a control group with parallel double-blind phase 3 groups on 210 patients. After the randomization, the patients will be divided into two intervention and control groups.
Settings and conduct
The study population is patients with angina pectoris who are candidates for coronary angiography, referring to Shahid Madani Hospital in Khorramabad.The study is double-blind.The participating patients and the doctor are blinded. In the intervention group, patients are treated with three doses of drugs. Colchicine is given before and after the procedure. Also, in the control group, three doses of placebo will be given in the same order. In both groups. The amount of troponin will be measured before the procedure and also 24 hours after the procedure with a quantitative troponin kit.
Participants/Inclusion and exclusion criteria
The most important criterion for entering is: stable and unstable angina pectoris and non-ST segment elevation myocardial infarction diagnosed by a cardiologist and candidate for coronary angiography.
Inclusion criteria: having sensitivity to colchicine and not being a candidate for angioplasty after angiography and glomerular filtration below 30 ml/min.
Intervention groups
In the intervention group, patients will first receive 1 mg of colchicine 12 to 24 hours before the study and half a mg one hour later. They will also receive half a milligram of colchicine half an hour after the procedure.
Patients in the control group will receive the same placebo drug as the intervention group
Main outcome variables
Troponin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059731N1
Registration date:2023-11-27, 1402/09/06
Registration timing:registered_while_recruiting
Last update:2023-11-27, 1402/09/06
Update count:0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Zohre Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 9222
Email address
dr.taheri96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of colchicine on reducing myocardial injury caused by coronary angioplasty procedure in patients with coronary artery disease
Public title
The effect of colchicine on reducing myocardial injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from stable and unstable angina pectoris and myocardial infarction without ST segment elevation diagnosed by a cardiologist and a candidate for coronary angiography
Not taking colchicine due to other diseases such as gout
Not having a history of myelodysplasia
Not taking corticosteroids or non-steroidal anti-inflammatory drugs except aspirin for 3 days before
Absence of malignancy or active infection
Exclusion criteria:
Being allergic to colchicine
Not being a candidate for angioplasty after angiography
Glomerular filtration below 30 ml/min
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in groups is done using block randomization method and patients are placed in 2 study groups in a balanced way by block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients in both intervention and control groups have no information regarding receiving or not receiving placebo. Also, the doctor of Intervention has no information regarding which study group the patient undergoing angioplasty is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square, Khorramabad city
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.LUMS.REC.1402.229
Health conditions studied
1
Description of health condition studied
Coronary artery disease with angina pectoris
ICD-10 code
I25.11
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with angina pectoris
Primary outcomes
1
Description
Troponin
Timepoint
Troponin measurement is done 12 to 24 hours before the angioplasty procedure and also 24 hours after the procedure.
Method of measurement
The level of troponin will be measured 12 to 24 hours before the procedure, exactly before receiving the first dose of the drug or placebo, and also 24 hours after the procedure by the laboratory technician with the HUBI TNI troponin quantitative kit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients will first receive 1 mg of colchicine (produced by Hashtgerd-Iran Mofid Pharmaceutical Company) 12 to 24 hours before the study and half a mg one hour later. Also, half an hour after the procedure, patients in the intervention group will receive a third dose of medicine equivalent to half a milligram of colchicine to maintain the anti-inflammatory effect of colchicine until 24 hours after the procedure.
Category
Treatment - Drugs
2
Description
Control group: Patients in the placebo control group, which is exactly the same as colchicine in terms of color and size, will receive the first dose 12 to 24 hours before and the second dose one hour later. They will also receive the third dose half an hour after the procedure. Also, the level of troponin before and 24 hours after the procedure in this group will be measured in the same way as the intervention group with a troponin quantitative kit by the laboratory technician.It should be noted that the content of placebo is starch, which is without complications for patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Hospital
Full name of responsible person
Seyede Zohre Taheri
Street address
second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3322 9222
Email
dr.taheri96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Bahram Rasoolian
Street address
Khorramabad city, Anoushirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 916 667 9738
Email
bahramrasoulian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyede Zohre Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3322 9222
Email
dr.taheri96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyede Zohre Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3322 9222
Email
dr.taheri96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyede Zohre Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3322 9222
Email
dr.taheri96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Demographic information of patients without revealing their names, data from statistical analysis, information related to the main outcome of the study
When the data will become available and for how long
Up to one year after completing the study
To whom data/document is available
All members of society
Under which criteria data/document could be used
After statistical analysis
From where data/document is obtainable
Principal investigator
What processes are involved for a request to access data/document
Application through the Honorable Deputy of University Research and Deputy of Research of Shahid Madani Hospital