Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00689611
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2008-05-30
Brief Title:
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome The ZESCA Trial
Sponsor:
Mark Eisenberg
Organization:
McGill University
Study Overview
Official Title:
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome The ZESCA Trial
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
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:
ZESCA
Brief Summary:
Patients who continue to smoke after a heart attack have a 35 increased risk of a recurrent event or death compared with those who quit Many patients attempt to stop smoking after a heart attack but relapse rates approach 66 A variety of smoking cessation aids have been shown to be effective for the general population However bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers Furthermore nicotine replacement therapies NRTs are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine Although bupropion has been successfully used to reduce smoking rates in healthy young populations its efficacy and safety in the setting of patients recovering from an ACS is unknown These patients if they continue to smoke are at exceptionally high risk for recurrent cardiac events If bupropion is effective in this population it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack
Detailed Description:
Patients who continue smoking after ACS have a 35 increased risk of reinfarction or death compared with those who quit Many patients attempt to stop smoking after an acute coronary syndrome ACS but relapse rates approach 66 A variety of smoking cessation aids have been shown to be effective for the general population However physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50 Although bupropion has successfully been used to reduce smoking rates in healthy young populations its efficacy and safety in the setting of patients recovering from an ACS is unknown
The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS The ZESCA Trial will be a multi-center effort coordinated from the Jewish General HospitalMcGill University Montreal Quebec A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site Prior to the start of the treatment patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation Patients will begin treatment in-hospital and will be monitored in-hospital for 2 days prior to discharge Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks Prior to discharge the patients will receive an information sheet listing the possible side effects of bupropion They will be advised to consult the treating physician should they experience any listed side effects While in-hospital patients will have quit smoking and they will be instructed to not restart smoking when discharged Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period In addition the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12 Smoking abstinence will be assessed at 4 weeks 9 weeks 6 months and 12 months after randomization Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide 10 ppm Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 by telephone calls and weeks 4 and 9 as well as months 6 and 12 by clinic visits Withdrawal symptoms will also be assessed by the nurses during their weekly calls
Trials previously conducted with bupropion involved young healthy smokers The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS These patients if they continue to smoke are at exceptionally high risk for recurrent cardiac events If bupropion is effective in this population it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS
The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS The ZESCA Trial will be a multi-center effort coordinated from the Jewish General HospitalMcGill University Montreal Quebec A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site Prior to the start of the treatment patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation Patients will begin treatment in-hospital and will be monitored in-hospital for 2 days prior to discharge Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks Prior to discharge the patients will receive an information sheet listing the possible side effects of bupropion They will be advised to consult the treating physician should they experience any listed side effects While in-hospital patients will have quit smoking and they will be instructed to not restart smoking when discharged Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period In addition the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12 Smoking abstinence will be assessed at 4 weeks 9 weeks 6 months and 12 months after randomization Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide 10 ppm Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 by telephone calls and weeks 4 and 9 as well as months 6 and 12 by clinic visits Withdrawal symptoms will also be assessed by the nurses during their weekly calls
Trials previously conducted with bupropion involved young healthy smokers The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS These patients if they continue to smoke are at exceptionally high risk for recurrent cardiac events If bupropion is effective in this population it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN75356261 | None | None | None |