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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: placebo; Drug: varenicline tartrate; Drug: bupropion hydrochloride; Drug: Nicotine Replacement Therapy Patch

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: Interventional
• Enrollment (Actual): 4595
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, C1440BRR
      • Centro de Investigacion Clinica WM
  • Capital Federal
    • Buenos Aires, Capital Federal, Argentina, C1426ABP
      • Centro Médico Dra. De Salvo
• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Monash Alfred Psychiatry Research Centre
• Brazil
  • Sao Paulo, Brazil, 05017-000
    • Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
  • São Paulo
    • Campinas, São Paulo, Brazil, 13059-740
      • Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
• Bulgaria
  • Bourgas, Bulgaria, 8000
    • Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
  • Kazanlak, Bulgaria, 6100
    • MHAT "Dr. Hristo Stambolski" Ltd.
  • Novi Iskar, Bulgaria, 1282
    • NPH "Sv. Ivan Rilski"
  • Pleven, Bulgaria, 5800
    • UMHAT "Dr. Georgi Stranski" Ltd.
  • Plovdiv, Bulgaria, 4002
    • UMHAT "Sveti Georgi" Ltd.
  • Ruse, Bulgaria, 7002
    • SHATPPD - Ruse Ltd.
  • Ruse, Bulgaria, 7004
    • Mental Health Center - Ruse Ltd.
  • Sofia, Bulgaria, 1113
    • MHATNP "Sveti Naum" Ltd.
  • Sofia, Bulgaria, 1113
    • MHATNP Sveti Naum SJsc.
  • Troyan, Bulgaria, 5600
    • SHATPD - Troyan Ltd.
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Medical Research Group
    • Mississauga, Ontario, Canada, L5M 4N4
      • Medical Research Associates
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M3J 2C5
      • Canadian Phase Onward Inc.
    • Toronto, Ontario, Canada, M5S 2S1
      • Centre for Addiction and Mental Health (CAMH)
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Chile
  • Maule
    • Talca, Maule, Chile, 3460001
      • Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
  • Valparaiso, V Region
    • Quillota, Valparaiso, V Region, Chile, 2260877
      • Centro Respiratorio Integral (CENRESIN Ltda.)
• Denmark
  • Ballerup, Denmark, 2750
    • CCBR A/S
  • Vejle, Denmark, DK-7100
    • CCBR A/S
• Finland
  • Espoo, Finland, 02600
    • Mehiläinen Leppävaara
  • Kuopio, Finland, 70110
    • Savon Psykiatripalvelu Oy
  • Nummela, Finland, 03100
    • Mehiläinen Nummela
  • Oulu, Finland, 90100
    • Oulu Mentalcare Oy
  • Pori, Finland, 28100
    • Porin Lääkäritalo Oy
  • Turku, Finland, 20100
    • PEL, Psykiatrian ErikoisLääkärit
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Leipzig, Germany, 04157
    • ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
  • Tuebingen, Germany, 72076
    • Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
  • Baden-wuerttemberg
    • Freiburg, Baden-wuerttemberg, Germany, 79104
      • Universitaetsklinikum Freiburg
  • Bayern
    • Muenchen, Bayern, Germany, 80336
      • Ludwig Maximilians-Universitaet Muenchen
• Mexico
  • Mexico Df
    • Mexico, Mexico Df, Mexico, 06100
      • Consultorios de Medicina Especializada del Sector Privado
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64620
      • Centro de Estudios Clínicos y Especialidades Médicas S.C.
• New Zealand
  • Rotorua, New Zealand, 3010
    • Lakeland Clinical Trials
• Russian Federation
  • Moscow, Russian Federation, 107076
    • FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
  • Moscow, Russian Federation, 117152
    • Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
  • Moscow, Russian Federation, 125367
    • Clinical Mental Hospital #12 of Moscow Healthcare Department
  • Nizhni Novgorod, Russian Federation, 603155
    • Clinical Psychiatric Hospital #1 of Nizhni Novgorod
  • Saint Petersburg, Russian Federation, 192019
    • FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
  • St. Petersburg, Russian Federation, 190121
    • St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
  • St. Petersburg, Russian Federation, 197341
    • State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2
• Slovakia
  • Bratislava, Slovakia, 82007
    • Psychiatricka ambulancia, Mentum, s.r.o.
  • Bratislava, Slovakia, 851 01
    • Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
  • Levice, Slovakia, 93401
    • Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
  • Rimavska Sobota, Slovakia, 979 01
    • Psychiatricka ambulancia, PsychoLine s.r.o.
  • Roznava, Slovakia, 04801
    • Nemocnica s poliklinikou sv. Barbory Roznava a.s.
• South Africa
  • Cape Town
    • Bellville, Cape Town, South Africa, 7530
      • Flexivest Fourteen Research Center
  • Gauteng
    • Benoni, Johannesburg, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Johannesburg, Gauteng, South Africa, 1818
      • Soweto Clinical Trials Centre
    • Midrand, Gauteng, South Africa, 1685
      • Midrand Medical Centre
    • Pretoria, Gauteng, South Africa, 0157
      • I Engelbrecht Research Pty. Ltd
    • Pretoria, Gauteng, South Africa, 0157
      • Vista Clinic
  • Kwa-zulu Natal, South Africa
    • Durban, Kwa-zulu Natal, South Africa, South Africa, 4019
      • Private Practice
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa, 4091
      • Randles Road Medical Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 8001
      • Dr John O'Brien Incorporated
• Spain
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall d'Hebron
  • Caceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Madrid, Spain, 28015
    • Unidad Especializada en Tabaquismo de la Comunidad de Madrid
  • Zaragoza, Spain, 50007
    • Centro de Salud Torrero-La Paz.
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Escondido, California, United States, 92025
      • Synergy Clinical Research Center Of Escondido
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • La Habra, California, United States, 90631
      • Omega Clinical Trials
    • La Jolla, California, United States, 92037
      • Pacific Treatment and Research Center
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute (PRI)
    • Oceanside, California, United States, 92056
      • North County Clinical Research
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program
    • Denver, Colorado, United States, 80209
      • Western Affiliated Research Institute
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Hollywood, Florida, United States, 33024
      • Broward Research Group
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34474
      • Ocala Psychiatric Associates
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions Inc.
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Baber Research Group Incorporated
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research, LLC
    • Indianapolis, Indiana, United States, 46250
      • Davis Clinic, Incorporated
    • Indianapolis, Indiana, United States, 46254
      • American Health Network of IN, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research, Inc.
    • Overland Park, Kansas, United States, 66212
      • Vince & Associates Clinical Research, Inc.
    • Overland Park, Kansas, United States, 66211
      • Vince & Associates Clinical Research, Inc.
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Incorporated
    • Louisville, Kentucky, United States, 40218
      • Kentucky Research Group
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • The Center for Sexual Health
  • Maine
    • Auburn, Maine, United States, 04210
      • Maine Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Milford, Massachusetts, United States, 01757
      • Milford Emergency Associates, Incorporated
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota - TC
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, PC
    • St. Louis, Missouri, United States, 63141
      • Mercy Health Research
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • CRI Worldwide, LLC
    • Princeton, New Jersey, United States, 08540
      • Global Medicinal Institutes, LLC; Princeton Medical Institute
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trails LLC
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Incorporated
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Internal Medicine Consultants, Inc
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Science University
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Southeastern PA Medical Institute
    • Philadelphia, Pennsylvania, United States, 19131
      • Belmont Center For Comprehensive Treatment
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research, LLC
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions,Inc
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
    • Nashville, Tennessee, United States, 37203
      • James G. Kyser, MD
  • Texas
    • Austin, Texas, United States, 78731
      • Future Search Clinical Trials
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77030-1439
      • The University of Texas M.D. Anderson Cancer Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: placebo	Drug: placebo; All dosing to have taken place per study A3051123
Experimental: varenicline	Drug: varenicline tartrate; All dosing to have taken place per study A3051123; Other Names: Chantix; Champix
Experimental: bupropion	Drug: bupropion hydrochloride; All dosing to have taken place per study A3051123; Other Names: Zyban
Experimental: Nicotine Replacement Therapy Patch	Drug: Nicotine Replacement Therapy Patch; All dosing to have taken place per study A3051123; Other Names: NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.	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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.	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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.
Time to MACE Until the End of 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.	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).
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.	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).	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.	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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.	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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) 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.	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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
Incidence of MACE Assessed Until End of 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.	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).
Incidence of MACE+ Assessed Until End of 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.	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).

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: cardiovascular events; smoking cessation; psychiatric disease
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: A3051148; 2011-005513-37 (EudraCT Number); CATS (Other Identifier: Alias Study Number)