Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
ZESCA
2 other identifiers
interventional
392
7 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 30, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
April 23, 2015
CompletedApril 23, 2015
April 1, 2015
4.5 years
May 30, 2008
December 11, 2013
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Abstinence
The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm. The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.
12 months
Secondary Outcomes (1)
Composite Major Adverse Cardiovascular Events (MACE)
12 months
Study Arms (2)
P
PLACEBO COMPARATORHalf of patients will receive placebo for 9 weeks.
A
ACTIVE COMPARATORHalf of patients will receive bupropion for 9 weeks.
Interventions
150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Smoke at least 10 cigarettes/day for the past year
- Suffered an enzyme-positive ACS
- Planned hospitalization of ≥24 hours
- Motivated to quit smoking
- Likely to be available for follow-up
- Able to understand and read English or French
You may not qualify if:
- Medical condition with a prognosis of \< 1 year
- Pregnant or lactating
- Current use of Wellbutrin or any other medications that contain bupropion
- Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)
- Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)
- History of bulimia or anorexia nervosa
- Current diagnosis of major depression (requiring medication), bipolar disease, or dementia
- History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide
- Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels ≥ 2 times upper limit of normal prior to admission for ACS)
- Renal impairment with creatinine levels ≥ 2 times the upper limit of normal
- Excessive alcohol consumption defined as ≥ 14 alcoholic drinks per week
- Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates)
- Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinolone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)
- Use of MAO inhibitors or thioridazine in the past 15 days
- Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anoretics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mark Eisenberglead
- Canadian Institutes of Health Research (CIHR)collaborator
- Heart and Stroke Foundation of Canadacollaborator
Study Sites (38)
Parkview Medcial Center
Pueblo, Colorado, 81003, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Bassett Healthcare
Cooperstown, New York, 13326, United States
United Health Services
Johnson City, New York, 13790, United States
Stony Brook Hospital and Medical Center
Stony Brook, New York, 11794-8167, United States
Schuster Cardiology
Kettering, Ohio, 45429, United States
Southwest Cardiology
Kettering, Ohio, 45429, United States
DVA Medical Center
Oklahoma City, Oklahoma, 73104, United States
Advanced Cardiology Specialists
Scranton, Pennsylvania, 18501, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Riverside Hospital
Newport News, Virginia, 23601, United States
Charleston Area Medical Center
South Charleston, West Virginia, 25309, United States
National Heart Foundation of Bangladesh
Dhaka, Bangladesh
Peter Lougheed Centre of the Calgary General Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Coastal Health
Vancouver, British Columbia, V5M 1L9, Canada
Victoria General Hospital
Winnipeg, Manitoba, R3T 2E8, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
New Brunswick Heart Centre
Saint Johns, New Brunswick, Canada
Valley Regional Hospital
Kentville, Nova Scotia, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hopital de la Cite de la Sante
Laval, Quebec, H7M 3L9, Canada
CHA Hotel-Dieu de Levis
Lévis, Quebec, Canada
SMBD- Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Hopital Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Hotel-Dieu
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Hopital Laval
Québec, Quebec, G1V 4G5, Canada
Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
CSSS de Sorel-Tracy
Sorel-Tracy, Quebec, Canada
CSSS de la Region de Thetford
Thetford-Mines, Quebec, Canada
Saskatchewan Drug Research Institute
Saskatoon, Saskatchewan, S7N 0W8, Canada
Centre for Chronic Disease Control
New Delhi, India
Isfahan Cardiovascular Research Centre
Isfahan, Iran, Iran
InterActive Research and Development
Karachi, Pakistan
University Hospital F. Bourguiba
Sousse, Sousse Governorate, Tunisia
Related Publications (5)
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVEDHartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PMID: 34611902DERIVEDTaylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.
PMID: 33687070DERIVEDZhang DD, Eisenberg MJ, Grandi SM, Joseph L, O'Loughlin J, Paradis G, Lozano P, Filion KB. Bupropion, smoking cessation, and health-related quality of life following an acute myocardial infarction. J Popul Ther Clin Pharmacol. 2014;21(3):e346-56. Epub 2014 Oct 8.
PMID: 25326910DERIVEDShimony A, Grandi SM, Pilote L, Joseph L, O'Loughlin J, Paradis G, Rinfret S, Sarrafzadegan N, Adamjee N, Yadav R, Gamra H, Diodati JG, Eisenberg MJ; ZESCA Investigators. Utilization of evidence-based therapy for acute coronary syndrome in high-income and low/middle-income countries. Am J Cardiol. 2014 Mar 1;113(5):793-7. doi: 10.1016/j.amjcard.2013.11.024. Epub 2013 Dec 12.
PMID: 24440324DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Relatively high number who withdrew or were lost to follow-up (22.2%), but within expectations for smoking cessation trials; Relatively small numbers of serious adverse events occurred, limiting power to examine secondary safety end points.
Results Point of Contact
- Title
- Dr. Mark J. Eisenberg
- Organization
- Divisions of Cardiology and Clinical Epidemiology, Jewish General Hospital/McGill University
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Eisenberg, MD, MPH
Jewish General Hospital/ McGill University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, MPH, Professor of Medicine
Study Record Dates
First Submitted
May 30, 2008
First Posted
June 3, 2008
Study Start
December 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 23, 2015
Results First Posted
April 23, 2015
Record last verified: 2015-04