Ignite Creation Date:
2024-05-06 @ 2:42 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02106637
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2014-03-27
Brief Title:
Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation Patients After ACS
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation Concomitant With Nurse-Led Support in Patients After an Acute Coronary Syndrome ACS
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS as compared with nurse led support and placebo without a significant increase in the risk of adverse events
Detailed Description:
Smokers hospitalized with Acute Coronary Syndrome ACS are at high risk for ischemic events or death Over two thirds of patients continue to smoke after acute myocardial infarction
Study objectives will evaluate safety and efficacy of Varenicline vs placebo in hospitalized ACS patients complemented by nurse-led support Interventions will continue following discharge for the duration of 12 weeks
The primary efficacy outcome measure is continuous abstinence rate at 1 year after hospitalization as assessed by self-reporting and verified by CO breath test
The proposed study is a prospective double blind randomized placebo controlled multi-center study Overall 300 patients will be recruited randomly allocated to active and placebo treatment groups that will receive nurse-led support by trained staff
Hospitalized ACS smokers will be evaluated by the protocol inclusionexclusion criteria Patients demographics medical and laboratory data will be obtained including Fagestrom tobacco addiction questionnaire and digitally captured Participants will be randomly allocated to study groups and will receive Varenicline or placebo which will be initiated on the last day of hospitalization and continued for 12 weeks after discharge Additionally a structured nurse-led behavioral support program for smoking cessation will be initiated during hospitalization followed by telephone calls that will provide motivational support and an interview exploring protocol adherence side effects changes in health status and smoking status
All patients will be re-assessed at one 3 and 12 -months post discharge Follow-up visits will comprise of a physical examination adverse event assessment and CO breath testing
Cardiovascular diseases are the leading cause of death in Western countries and cigarette smoking has a clear cause-and -effect relationship with atherosclerotic disease 1 Smokers hospitalized with Acute Coronary Syndrome ACS are at high risk for subsequent ischemic events and present 50 higher chance of death in the first 2 years 2 Nevertheless over two thirds of patients continue to smoke after an acute myocardial infarction Varenicline has been shown to be highly effective smoking cessation intervention 4 yet concerns have been raised regarding safety in coronary patients 5
A significant number of eligible patients do not receive structured smoking cessation interventions following ACS Initiation of secondary prevention interventions during hospital stay has been shown to be highly effective for other key secondary prevention interventions ie statins beta blockers
Moreover combination of Varenicline treatment with nurse-led hospital support initiated early during hospitalization is expected to result in better adherence and better long-term abstinence rates in smokers with a recent ACS
This proposed study would be the first Israeli trial with Varenicline
Study objectives will evaluate safety and efficacy of Varenicline vs placebo in hospitalized ACS patients complemented by nurse-led support Interventions will continue following discharge for the duration of 12 weeks
The primary efficacy outcome measure is continuous abstinence rate at 1 year after hospitalization as assessed by self-reporting and verified by CO breath test
The proposed study is a prospective double blind randomized placebo controlled multi-center study Overall 300 patients will be recruited randomly allocated to active and placebo treatment groups that will receive nurse-led support by trained staff
Hospitalized ACS smokers will be evaluated by the protocol inclusionexclusion criteria Patients demographics medical and laboratory data will be obtained including Fagestrom tobacco addiction questionnaire and digitally captured Participants will be randomly allocated to study groups and will receive Varenicline or placebo which will be initiated on the last day of hospitalization and continued for 12 weeks after discharge Additionally a structured nurse-led behavioral support program for smoking cessation will be initiated during hospitalization followed by telephone calls that will provide motivational support and an interview exploring protocol adherence side effects changes in health status and smoking status
All patients will be re-assessed at one 3 and 12 -months post discharge Follow-up visits will comprise of a physical examination adverse event assessment and CO breath testing
Cardiovascular diseases are the leading cause of death in Western countries and cigarette smoking has a clear cause-and -effect relationship with atherosclerotic disease 1 Smokers hospitalized with Acute Coronary Syndrome ACS are at high risk for subsequent ischemic events and present 50 higher chance of death in the first 2 years 2 Nevertheless over two thirds of patients continue to smoke after an acute myocardial infarction Varenicline has been shown to be highly effective smoking cessation intervention 4 yet concerns have been raised regarding safety in coronary patients 5
A significant number of eligible patients do not receive structured smoking cessation interventions following ACS Initiation of secondary prevention interventions during hospital stay has been shown to be highly effective for other key secondary prevention interventions ie statins beta blockers
Moreover combination of Varenicline treatment with nurse-led hospital support initiated early during hospitalization is expected to result in better adherence and better long-term abstinence rates in smokers with a recent ACS
This proposed study would be the first Israeli trial with Varenicline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None