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Evaluation of the low dose colchicine on the clinical outcome of patient with ST elevation myocardial infarction

Protocol summary

Study aim
Evaluation of the low dose colchicine on the clinical outcome of patient with ST elevation myocardial infarction.
Design
This study will be conducted as a double-blind clinical trial in two intervention and control groups with block randomization. In each group, 90 patients will be included in the study. The subject of intervention in this study is the drug colchicine with a dose of 0.5 mg, which is prescribed for patients in the intervention group, and placebo will be prescribed for patients in the control group. All patients will meet the study entry criteria.
Settings and conduct
This study will be conducted during the years 1401 and 1402 in the CCU and post-CCU departments of Shahid Beheshti Hospital, Qom. In order to observe blinding, the researcher and the examiner (evaluator of the patients during the follow-up period) will be unaware of the type of treatment group of the patients. After randomization, each patient will receive colchicine or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age range from 18 to 80 years 2. Occurrence of STE in the patient's ECG. Exclusion Criteria: 1. Unstable vital signs of patients 2. Known drug sensitivity to colchicine 3. Severe liver and kidney disease 4. Chronic treatment with colchicine
Intervention groups
The intervention in this study is colchicine with a dose of 0.5 mg, which is prescribed for the patients of the intervention group, and the placebo drug, which is similar to colchicine in terms of color, size and packaging, will be prescribed for the patients of the control group.
Main outcome variables
Functional class of the patient until the occurrence of chest pain, need for re-hospitalization, mortality rate of patients, information obtained from echocardiography of patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231001059578N1
Registration date: 2023-10-21, 1402/07/29
Registration timing: registered_while_recruiting

Last update: 2023-10-21, 1402/07/29
Update count: 0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
َAli Khosrobeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
ali.khosrobeigi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-03, 1402/07/11
Expected recruitment end date
2024-01-31, 1402/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the low dose colchicine on the clinical outcome of patient with ST elevation myocardial infarction
Public title
Evaluation of the colchicine on the myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 80 years old patient Occurrence of STE in the patient's ECG
Exclusion criteria:
Unstable vital signs of patients Known drug sensitivity to colchicine Severe liver and kidney disease Chronic treatment with colchicine
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
A lottery method will be used to assign patients to two intervention and control groups. In the first stage, the groups are written in the form of group A, B. Then, a lottery is drawn between the two groups to determine which is the intervention group and which is the control group. In the second step, the numbers of two cards written on one A and the other B and completely closed and not visible are thrown into a container. In the third stage, after obtaining consent from the patients and agreeing to participate in the study, they are asked to choose one of the two cards in the container in order to determine the treatment group. Then he takes a card from inside the container and hands it to the nurse. The nurse writes down the treatment group and the patient's medicine is prescribed according to the group it belongs to. This work will continue until 90 people in both groups are completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blinding, the researcher and the patient will be unaware of the type of treatment group of the patients. The intervention in this study is colchicine with a dose of 0.5 mg, which is prescribed for the patients of the intervention group, and the placebo drug, which is similar to colchicine in terms of color, size and packaging, will be prescribed for the patients of the control group. Labeling, blinding, packaging of drugs and delivery of drugs to patients will be done by a person not familiar with the study (ward head).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Shahid Lavasani St. (Saheli) - Qom University of Medical Sciences - Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.MUQ.REC.1401.235

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
the functional class of the patient until the occurrence of chest pain
Timepoint
At the beginning of the study, the first day, when the patients were discharged and after 40 days from intervention
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
An oral loading dose of 2 mg equivalent to 2 colchicine (from Mofid Pharma Pharmaceutical Company) tablets will be given to the patients, followed by 0.5 mg once a day orally for 30 days.
Category
Treatment - Drugs

2

Description
Control group: Placebo (from Mofid Pharma Pharmaceutical Company) medicine, which is similar to colchicine in terms of color, size and packaging, will be prescribed for control group patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Qom
Full name of responsible person
Ali Khosrobeigi
Street address
Shahid Beheshti Hospital, Qom
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
ali.khosrobeigi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
ali khosrobeigi
Street address
Shahid Beheshti Street, Shahid Beheshti Hospital, Qom
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Email
ali.khosrobeigi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Ali khosrobeigi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
shahid beheshti hospital Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Email
ali.khosrobeigi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ali khosrobeigi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
shahid beheshti hospital Qom
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Email
ali.khosrobeigi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
َAli Khosrobeigi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shahid beheshti hospital, shahid beheshti street qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Fax
Email
ali.khosrobeigi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
from 2024
To whom data/document is available
all people
Under which criteria data/document could be used
If the data and documents of this study are needed to conduct larger studies, the administrators of this study will provide all the data to the administrators of other studies.
From where data/document is obtainable
dr khosrobeigi, ali.khosrobeigi@gmail.com
What processes are involved for a request to access data/document
ali.khosrobeigi@gmail.com
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