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Evaluation of the effect of Colchicine therapy in patient presenting with non ST-elevation myocardial infarction

Protocol summary

Study aim
Evaluation of the effect of Colchicine therapy in patients presenting with non ST-elevation myocardial infarction
Design
Randomized, superiority, parallel group with double blind clinical trial. Simple randomization was performed using sealed envelope. Sample size calculated according to high sensitive CRP as the main outcome and error of the first kind=5% and second type=10% and Comparison of two means formula, per group 70 patients.
Settings and conduct
The study will performed in 2019-2020 in Ghaem & Imam Reza hospitals in mashhad. Patients in intervention and control groups respectively take Colchicine (0.5mg tiwce daily if weight more than 75 Kg & 0.5mg daily if weight less than 75 Kg or GFR less than 50) and placebo. For patients, evaluators and analysts will be blinded. Initial laberatory tests Include CBC diff, hsCRP, ESR, Total cholesterol, HDL & LDL cholesterol, TG, Cr, CPK, ALP, AST, ALT, hsTroponin at hospitalize time and after 4 weeks will checked. By comparing data, results of the study will achieve.
Participants/Inclusion and exclusion criteria
Condition of entrace: Patients presenting with non STEMI Non-entry condition: Renal failure & hemodialysis, GFR<30, thrombocytopenia, Sever hepatic failure, Dyspepsia, Chronic diarrhea, Under treatment by corticosteroids or immunosuppressive medications or Diltiazem or verapamil
Intervention groups
In intervention group and control group, patients will be treated by Colchicine and placebo
Main outcome variables
high sensitive CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190601043780N1
Registration date: 2019-08-26, 1398/06/04
Registration timing: registered_while_recruiting

Last update: 2019-08-26, 1398/06/04
Update count: 0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Hossein Naghedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4936
Email address
naghediniah951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Colchicine therapy in patient presenting with non ST-elevation myocardial infarction
Public title
Effect of Colchicine in patient presenting with non ST-elevation myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient presenting with non ST-elevation myocardial infarction
Exclusion criteria:
Patients under hemodialysis GFR<30 thrombocytopenia Severe Liver Failure (Liver enzyme > 3 times of normal) dyspepsia or chronic diarrhea Under treatment by corticosteroids or immunosuppressive medications Under treatment by verapamil or diltiazem
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by Enclosed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients initially divide in groups 1 and 2, using simple randomization method. Both groups, receive another drug wich add to main medication that is packed in the same package as No. 1 or 2. The Physician and other Partners did not know the numbers assigned to the drug or placebo. The relevant information is provided in a closed envelope by a pharmaceutical company. After the data collection and analysis are completed, the envelope will be open and drug and placebo group will be identified.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of medicine science, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.088

Health conditions studied

1

Description of health condition studied
Non-ST elevation (NSTEMI) myocardial infarction
ICD-10 code
I21.4
ICD-10 code description
Non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
hs-CRP
Timepoint
At the beginning of the study (before the intervention) and 4 weeks after the start of taking colchicine
Method of measurement
Biochemistry Lab (human hs crp elisa kit)

Secondary outcomes

1

Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At the beginning of the study (before the intervention) and 4 weeks after the start of taking colchicine
Method of measurement
Biochemistry Lab

2

Description
mean platelet volume
Timepoint
At the beginning of the study (before the intervention) and 4 weeks after the start of taking colchicine
Method of measurement
hematology Lab

3

Description
LDL cholesterol
Timepoint
At the beginning of the study (before the intervention) and 4 weeks after the start of taking colchicine
Method of measurement
Biochemistry Lab

Intervention groups

1

Description
Intervention group: Patients more than 75 kg of body weight take 1 mg/day colchicine and patients less than 75 Kg of body weight take 0.5 mg/day of colchicine for 4 weeks
Category
Treatment - Drugs

2

Description
Control group: Patients take palcebo in this group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Gholoobi Arash
Street address
Department of Cardiology, Imam Reza hospital, Bahar Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 51 3854 3031
Email
GholoobiA@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Gholoobi Arash
Street address
Department of Cardiology, Ghaem hospital, Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 51 3840 0000
Email
GholoobiA@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Daneshgah Ave.,Mashhad University of medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Gholoobi Arash
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Bahar Ave. Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 915 514 0084
Email
gholoobia@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholoobi Arash
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
bahar Ave., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 915 514 0084
Email
gholoobia@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
naghedinia hossein
Position
proffesor assistent
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Bahar Ave., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9186617415
Phone
+98 51 3841 4936
Email
naghediniah951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality is the Condition of attending the study for patients.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Protocol of study design Consent form for conscious Clinical study reports Data on the primary outcome and secondary outcomes
When the data will become available and for how long
3 Months after the results are published
To whom data/document is available
Researchers working in academic center
Under which criteria data/document could be used
By Email to Scientific Responsible for the Study GholoobiA@mums.ac.ir
From where data/document is obtainable
Scientific Responsible for the Study
What processes are involved for a request to access data/document
After assurance of working of applicant in academic center
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