Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

Official Title
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A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: placebo
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed > 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD). Participants that smoke > 10 cigarettes / day. Exclusion Criteria: Participants with unstable cardiovascular disease Cardiovascular events in the past 2 months Moderate or severe chronic obstructive pulmonary disease (COPD)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 1 mg placebo twice daily by mouth for 12 weeks<br>|
| Experimental: varenicline<br> | Drug: Varenicline<br>* 1 mg twice daily by mouth for 12 weeks<br>* Other names: Chantix, Champix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint. | weeks 9 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since last contact? = No AND 2) Has participant used any other tobacco products… since last contact? = No. Participant a non-responder if expired CO > 10 ppm. | Week 9 through Week 52 | 
| Number of Long-Term Quit Responders | Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | Week 9 through Week 52 | 
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm. | Week 12 | 
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm. | Week 24 | 
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm. | Week 52 | 
| Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study. | Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) | 
| Number of Responders With Continuous Abstinence (CA) Through Week 24 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since the last contact? = No AND 2) Has participant used any other tobacco products… since the last contact? = No. Non- responder if the expired CO > 10 ppm at any given timepoint. | Week 9 through Week 24 | 
| Cigarettes Smoked Per Day | Cigarettes smoked each day during the first 3 weeks of the treatment phase. | Day 21 | 
| Number of Long-Term Quit Responders From Week 9 Through Week 24 | Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | Week 9 through Week 24 |