Evaluation of the effect of Colchicine on the frequency of ventricular and supraventricular arrhythmias in patients with an implantable cardioverter-defibrillator
Determining the Effect of Colchicine on the Frequency of Ventricular and Supraventricular Arrhythmias in Patients with Implantable Cardioverter Defibrillators.
Design
A randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial involving 134 patients. Randomization was conducted using the website https://www.sealedenvelope.com/.
Settings and conduct
This study will be conducted on 134 eligible patients at a private physician's office in Mashhad. The study is double-blind, with the patient, investigator, and analyst all blinded. The drug and placebo will be divided into two groups, A and B, and will be randomly block-assigned to the participating patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients with implantable cardioverter defibrillators who visit the physician's office on an outpatient basis and provide informed consent to participate in the clinical trial.
exclusion criteria: Use of colchicine - Use of Class I and III antiarrhythmic drugs or anti-inflammatory medications - Moderate to severe renal dysfunction - Significant liver dysfunction - Suspected pregnancy or current pregnancy
Intervention groups
in Intervention group patients will receive one 1 mg Cochicine tablet daily for 3 months and in placebo group patients will receive one placebo tablet daily for 3 months.
Main outcome variables
Frequency of ventricular and supraventricular arrhythmias
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120520009801N13
Registration date:2024-06-01, 1403/03/12
Registration timing:prospective
Last update:2024-06-01, 1403/03/12
Update count:0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Colchicine on the frequency of ventricular and supraventricular arrhythmias in patients with an implantable cardioverter-defibrillator
Public title
Evaluation of the effect of colchicine on the frequency of ventricular and supraventricular arrhythmias
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Having an implantable cardioverter-defibrillator for more than 3 months before starting participation in the clinical trial
Obtaining the patient's informed consent
Exclusion criteria:
Taking the drug Colchicine before
Pregnancy or suspected pregnancy
Active inflammation or infection
Suffering from autoimmune diseases and malignancies
Taking class I and III antiarrhythmic drugs
Performing major surgeries
Treatment with corticosteroids or other immunosuppressive drugs
Moderate to severe kidney dysfunction (GFR < 30 ml/min/1.73m2)
Significant impairment of liver function (Child-Pugh class B or C)
Concomitant use of strong Cyp3A4 inhibitors
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate a random allocation sequence with the guarantee of equal allocation of individuals to two groups is permuted block randomization, created using the website https://www.sealedenvelope.com/. Specifically, 34 blocks of four will be randomly generated, and patients will be assigned to the study groups based on the sequence obtained from these blocks. Each block consists of four members and can take one of the following forms:
[AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB].
Code A corresponds to the intervention group, and code B corresponds to the control group. Therefore, 34 blocks of four will be randomly generated by the website, and patients will be allocated to the study groups according to the sequence obtained from these blocks.
The method of allocation concealment will be the use of sealed, opaque envelopes containing the random sequence obtained from the randomization step.
Blinding (investigator's opinion)
Double blinded
Blinding description
Codes A and B are assigned to the drug and placebo groups, respectively, and these codes are provided to the researcher present in the physician's office. It should be noted that this researcher is fully aware of the nature of the codes. Additionally, the drugs are provided to the researcher labeled with the corresponding code (A or B), and the researcher is fully aware of which is colchicine and which is the placebo.
It is noteworthy that the placebo, manufactured by the Pharmaceutics Laboratory of the School of Pharmacy, is identical in appearance to the colchicine tablet, ensuring that patients are unaware of whether they are in the drug or placebo group.
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
University Street - Next to Hoveyzeh Cinema - Ghorashi Building - Vice Chancellor for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.MUMS.REC.1403.027
Health conditions studied
1
Description of health condition studied
Ventricular arrhythmias
ICD-10 code
I47.0
ICD-10 code description
Re-entry ventricular arrhythmia
Primary outcomes
1
Description
Frequency of ventricular arrhythmias
Timepoint
The beginning of the study and 3 months later
Method of measurement
Examining the data obtained from the implantable cardiac defibrillator device
Secondary outcomes
1
Description
CRP level
Timepoint
Before the intervention and after 3 months
Method of measurement
Biochemistry test of the patient's blood sample
2
Description
blood pressure
Timepoint
Before the intervention and after 3 months
Method of measurement
sphygmomanometer
Intervention groups
1
Description
Intervention group: Intervention group:Colchicine 1 mg tablets, Mofid Pharmaceuticals, once a day for three months (67 people)
Category
Placebo
2
Description
Control group: Control group: Placebo tablets made by the School of Pharmacy of Mashhad University of Medical Sciences, one daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Tayyebi's office
Full name of responsible person
Mohammad Tayyebi
Street address
No. 11, between Besat 1 and 3, Molla Sadra and Besat intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3847 8514
Email
TayyebiM@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Street - Next to Hoveyzeh Cinema - Ghorashi Building - Vice Chancellor for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodiM@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
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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 unidentifiable individuals
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
The use of data is unimpeded by mentioning the source.
From where data/document is obtainable
Dr. AmirHoushang Mohamadpour Mail: mohamadpoorah@mums.ac.ir Phone: 09153162909
What processes are involved for a request to access data/document