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IRCT20200719048133N1 IRCT 2020-07-23 Tehran University of Medical Sciences Effect of Varenicline in smoking cessation after invasive treatment of coronary artery disease ٍEfficacy of Varenicline for smoking cessation among persistent smokers after coronary artery revascularization: A randomized placebo controlled clinical trial 2020-08-22 anticipated 600 Complete https://irct.ir/trial/49723 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. 4 Smoking cessation. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Masoumeh Lotfi Tokaldany
North Kargar Street
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9256 lotfi21366@yahoo.co.uk Tehran University of Medical Sciences scientific Saeed Sadeghian
North Kargar Street
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 ssadeghian@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Male 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 Treatment - Drugs Placebo 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. 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. 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. Tehran University of Medical Sciences Approved 2020-05-17 Ethics committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences End of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)