Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)

Tracking Information
First Submitted Date ICMJE	April 6, 2012
First Posted Date ICMJE	April 10, 2012
Results First Submitted Date	July 7, 2016
Results First Posted Date	December 29, 2016
Last Update Posted Date	December 29, 2016
Study Start Date ICMJE	May 2012
Actual Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 31, 2016)	Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]; This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
Original Primary Outcome Measures ICMJE; (submitted: April 9, 2012)	Time to major cardiovascular event (MACE; defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke) evaluated during the treatment phase (up to date of last dose of study drug in study A3051123) [ Time Frame: 12 weeks ]
Change History	Complete list of historical versions of study NCT01574703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 31, 2016)	Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. ]This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.; Time to MACE Until the End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.; Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).; Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.; Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ]This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.; Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ]This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.; Incidence of MACE Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.; Incidence of MACE+ Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Original Secondary Outcome Measures ICMJE; (submitted: April 9, 2012)	Time to MACE up to date of last dose of study drug plus 30 days in study A3051123 [ Time Frame: 16 weeks ]; Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ]; Incidence of each of the following events assessed up to date of last dose of study drug: [ Time Frame: 12 weeks ] MACE; MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization,or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.; Incidence of each of the following events will be assessed up to date of last dose of study drug plus 30 days. [ Time Frame: 16 weeks ] MACE; MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention,a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.; Incidence of each of the following events will be assessed until end of study: [ Time Frame: 52 weeks ] MACE; MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronaryrevascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Official Title ICMJE	A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary	Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
Detailed Description	This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
Condition ICMJE	Smoking Cessation
Intervention ICMJE	Drug: placebo All dosing to have taken place per study A3051123; Drug: varenicline tartrate All dosing to have taken place per study A3051123 Other Name: Chantix; Champix; Drug: bupropion hydrochloride All dosing to have taken place per study A3051123 Other Name: Zyban; Drug: Nicotine Replacement Therapy Patch All dosing to have taken place per study A3051123 Other Name: NRT
Study Arms	Experimental: placebo Intervention: Drug: placebo; Experimental: varenicline Intervention: Drug: varenicline tartrate; Experimental: bupropion Intervention: Drug: bupropion hydrochloride; Experimental: Nicotine Replacement Therapy Patch Intervention: Drug: Nicotine Replacement Therapy Patch
Publications *	Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 31, 2016)	4595
Original Estimated Enrollment ICMJE; (submitted: April 9, 2012)	8000
Actual Study Completion Date	July 2015
Actual Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Subjects will be eligible if they were randomized to study A3051123. Exclusion Criteria: Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Mexico, New Zealand, Russian Federation, Slovakia, South Africa, Spain, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01574703
Other Study ID Numbers ICMJE	A3051148; 2011-005513-37 ( EudraCT Number ); CATS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Pfizer
Study Sponsor ICMJE	Pfizer
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	October 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP