Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
Condition: Acute Coronary Syndrome; Myocardial Infarction; Smoking
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Syndrome; Infarction
Intervention: Bupropion HCl ER; Placebo
Intervention description: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks; Placebo
Intervention MeSH terms: Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute coronary syndrome; Myocardial infarction; Smoking cessation; Zyban; Secondary intervention post-ACS

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 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

        Exclusion Criteria:

          -  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