ٍEfficacy of Varenicline for smoking cessation among persistent smokers after coronary artery revascularization: A randomized placebo controlled clinical trial
The aim is to investigate the effect of Varenicline for smoking cessation in patients with coronary artery disease who continued smoking after coronary artery revascularization procedure
Design
A double-blind, randomized, placebo-controlled trial on 600 patients. A web-based randomization system will be used for randomization
Settings and conduct
The study will be conducted in Tehran Heart Center. Intervention will last for 13 weeks. All the participants will be followed up for 26 weeks after discontinuation of intervention to assess any ongoing abstinence.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male sex ≥ 18 years old
Current daily smoker of ≥ 5 cigarettes per day
Having a history of coronary artery revascularization procedure 9-12 months prior to the study
Able to consent to the study and to follow its instructions and procedures
Exclusion criteria:
1- Unstable cardiac disease
2- Known case of dementia disorders such as Alzheimer
3- Known case of chronic renal failure
3- Known or suspected unstable psychiatric disorders that require acute medical treatment
4- Only one member of a household is permitted to participate in the trial concurrently
to minimize cohort-confounding effects.
Intervention groups
The intervention group will receive Varenicline whereas the control group will be provided with placebo only. Patients in each arm will be instructed to use a 0.5 mg tablet (Varenicline/placebo) once daily for 3 days, a 0.5 mg tablet twice daily for 4 days and 1 mg tablet twice daily for remaining 12 weeks.
Main outcome variables
Between-group differences in the continuous abstinence rate at the end of 26 weeks follow up, the point prevalence abstinence, prolonged abstinence rate, participation rate and amount of smoking.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200719048133N1
Registration date:2020-07-23, 1399/05/02
Registration timing:prospective
Last update:2020-07-23, 1399/05/02
Update count:0
Registration date
2020-07-23, 1399/05/02
Registrant information
Name
Nazila Shahmansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
n.shahmansouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEfficacy of Varenicline for smoking cessation among persistent smokers after coronary artery revascularization: A randomized placebo controlled clinical trial
Public title
Effect of Varenicline in smoking cessation after invasive treatment of coronary artery disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male sex ≥ 18 years old
Current daily smoker of ≥ 5 cigarettes per day
Having a history of revascularization procedure for CAD in Tehran Heart 9-12 months prior to the study
Able to consent to the study and to follow its instructions and procedures
Exclusion criteria:
Unstable cardiac disease
Known case of dementia disorders such as Alzheimer
Known case of chronic renal failure
Known or suspected unstable psychiatric disorders that require acute medical treatment
Only one member of a household is permitted to participate in the trial concurrently to minimize cohort-confounding effects
Age
From 18 years old
Gender
Male
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
All of the participants will be assigned to either the intervention or placebo group. Block randomization with a variable block size of 2, 4, 6, 8, and 10 will be used for the allocation. A web-based randomization system will be used to generate randomization code by an independent researcher with no contact with the participants or other researchers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, the clinical practitioners, the nurse who will perform follow up contacts and the statistician who will analyses the data are all blinded during the clinical trial.
Placebo
Used
Assignment
Parallel
Other design features
Having coronary artery disease and performing invasive therapeutic interventions such as open heart surgery can increase a patient's motivation to quit smoking and cause them to quit smoking voluntarily. However, a considerable number of patients continue to smoke, regardless of the smoking role in subsequent cardiovascular events. The aim of this study is to evaluate the effectiveness of Varenicline in smoking cessation among patients who continue to smoke after experiencing open heart surgery or angioplasty treatment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Street address
End of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.077
Health conditions studied
1
Description of health condition studied
Smoking cessation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Group differences in the continuous abstinence rate
Timepoint
Point prevalence abstinence at the end of 13 and 52 weeks of intervention.
Method of measurement
Self-reported rating scales that is confirmed by one of the close relatives who lives with patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this arm will be instructed to use Varenicline based on the following protocol: A 0.5 mg tablet once daily for 3 days, A 0.5 mg tablet twice daily for 4 days and 1 mg tablet twice daily for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in this arm will be instructed to use placebo (identical tablets) based on the following protocol: A 0.5 mg tablet once daily for 3 days, A 0.5 mg tablet twice daily for 4 days and 1 mg tablet twice daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Masoumeh Lotfi Tokaldany
Street address
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
+98 21 8802 9257
Email
lotfi213366@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazila Shahmansouri
Street address
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9600
Email
n.shahmansouri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Lotfi Tokaldany
Position
None academic specialist member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
+98 21 8802 9257
Email
lotfi21366@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Sadeghian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9257
Email
ssadeghian@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Lotfi Tokaldany
Position
None academic specialist member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
+98 21 8802 9257
Email
lotfi21366@yahoo.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Not applicable
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document