Evaluation of anti-inflammatory effects of colchicine in patients with acute coronary syndrome
Design
This study will be performed as a phase 2 randomized double-blind randomized clinical trial on 80 patients with ST Elevated MI who are candidates for Primary PCI and present within less than 12 hours of the onset of pain.
Settings and conduct
Patients with ST Elevated MI who are candidates for Primary PCI and have referred to Rasoul Akram Hospital less than 12 hours after the onset of pain arerandomly (block randomization) and double-blind admitted to the study.
One group will be treated with colchicine and one group will receive placebo
In all patients, 2 cc of venous blood will be taken 24 hours after receiving the first dose of colchicine or placebo to measure IL 1B levels.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A patient with ST Elevated MI who is a candidate for Primary PCI and presented within less than 12 hours from the onset of pain
Conditions for not entering the study:
1. Cardiogenic shock or hemodynamic instability
2. Allergy to colchicine is known
3. Patients with a history of chronic kidney and liver disease
4. Thrombocytopenia or leukopenia
5. Pregnant or lactating women
6. Patients receiving CYP3A4 inhibitors
7. Patients who are already taking colchicine
8. Patients who have evidence of active or inflammatory infection
9. Patients with a history of previous AF and MI
11. Patients with a history of CABG
12. MI patients in the field of stent thrombosis
Intervention groups
The intervention group will receive colchicine 1 mg initially and 1 mg one hour after Primary PCI. . The control group will receive colchicine at the beginning and one hour after Primary PCI.
Main outcome variables
Assessment of interleukin 1B levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051047N2
Registration date:2021-09-10, 1400/06/19
Registration timing:retrospective
Last update:2021-09-10, 1400/06/19
Update count:0
Registration date
2021-09-10, 1400/06/19
Registrant information
Name
somayyeh nasiripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
nasiripours@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-27, 1400/04/06
Expected recruitment end date
2021-07-27, 1400/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anti-inflammatory effect of cholchicine in acute coronary syndrome
Public title
Colchicine in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient over 20 years of age with ST Elevated MI who is a candidate for Primary PCI and presented within less than 12 hours of the onset of pain
Exclusion criteria:
Cardiogenic shock or hemodynamic instability
Known hypersensitivity to colchicine
Patients with a history of chronic kidney and liver disease
Thrombocytopenia or leukopenia
Pregnant or lactating women
Patients receiving CYP3A4 inhibitors
Patients already taking colchicine
Patients who have evidence of active or inflammatory infection
Patients with a history of AF or MI
Patients with a history of CABG
MI patients in the field of stent thrombosis
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients, using random allocation software, were randomly divided into two groups. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers. The tool used is random allocation software version 2.0 in which by selecting the number of groups and the sample size, a random sequence sheet is provided for the control and intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be Triple-blind. The treating physician and patients will be blinded to the type of intervention and the data analyzer who must analyze the data ]will be blinded to the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2021-02-22, 1399/12/04
Ethics committee reference number
IR.IUMS.REC.1399.1296
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Assessment of interleukin 1B levels
Timepoint
24 hours after intervention
Method of measurement
Elisa Kit
Secondary outcomes
1
Description
Evaluation of recurrent myocardial infarction
Timepoint
On a daily basis from the start of the intervention
Method of measurement
Follow-up of symptoms of myocardial infarction
Intervention groups
1
Description
Intervention group: Patients receive 1 mg colchicine tablet made by Modava Pharmaceutical Company as 1 mg at first and 1 mg one hour after Primary PCI
Category
Treatment - Drugs
2
Description
Control group: Patients receive colchicine placebo made in the laboratory of Islamic Azad School of Pharmacy at the beginning and one hour after Primary PCI.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Somayyeh Nasiripour
Street address
niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
Nasiripours@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
1
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Farasatinasab
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
0098218214000
Email
maryfarasati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
nasiripours@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
nasiripours@yahoo.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
The study report will be available as an article
When the data will become available and for how long
September 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Upon written request and the protection of the rights of the study authorities, the approved items above will be available.
From where data/document is obtainable
Dr. Somayyeh Nasiripour, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences
Email: Nasiripours@yahoo.com
What processes are involved for a request to access data/document
Upon a written request, the study authorities will review it and then provide the documentation at its discretion.