Phase 3
Completed N=392
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
Source: ClinicalTrials.gov NCT00689611 ↗Enrolled (actual)
392
Serious AEs
18.1%
Results posted
Apr 2015
Primary outcomePrimary: Smoking Abstinence — 32.0; 37.2 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence |
32.0; 37.2 | — |
| SECONDARY Composite Major Adverse Cardiovascular Events (MACE) |
11.0; 13.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00689611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.