Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome, Myocardial Infarction, Smoking

In brief

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.

Key facts

Study ID

NCT00689611

Run by

Mark Eisenberg

People needed

392

Starts

2005-12-01

Expected to finish

2010-06-01

Last updated by the study team

2015-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Parkview Medcial Center — Pueblo, Colorado, United States
• Central Maine Medical Center — Lewiston, Maine, United States
• Bay Regional Medical Center — Bay City, Michigan, United States
• Bassett Healthcare — Cooperstown, New York, United States
• United Health Services — Johnson City, New York, United States
• Stony Brook Hospital and Medical Center — Stony Brook, New York, United States
• Schuster Cardiology — Kettering, Ohio, United States
• Southwest Cardiology — Kettering, Ohio, United States
• DVA Medical Center — Oklahoma City, Oklahoma, United States
• Advanced Cardiology Specialists — Scranton, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Riverside Hospital — Newport News, Virginia, United States
• Charleston Area Medical Center — South Charleston, West Virginia, 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, Canada
• Victoria General Hospital — Winnipeg, Manitoba, 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, Canada
• CHA Hotel-Dieu de Levis — Lévis, Quebec, Canada

Full record on ClinicalTrials.gov

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