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

Information source: McGill University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome; Myocardial Infarction; Smoking

Intervention: Bupropion HCl ER (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mark Eisenberg

Official(s) and/or principal investigator(s):
Mark J Eisenberg, MD, MPH, Principal Investigator, Affiliation: Jewish General Hospital/ McGill University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Smoking Abstinence

Secondary outcome: Composite Major Adverse Cardiovascular Events (MACE)

Detailed description: Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50%. Although bupropion has successfully been used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS. The ZESCA Trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site. Prior to the start of the treatment, patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation. Patients will begin treatment in-hospital and will be monitored in-hospital for ≥ 2 days prior to discharge. Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks. Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks. Prior to discharge, the patients will receive an information sheet listing the possible side effects of bupropion. They will be advised to consult the treating physician should they experience any listed side effects. While in-hospital, patients will have quit smoking and they will be instructed to not restart smoking when discharged. Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period. In addition, the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12. Smoking abstinence will be assessed at 4 weeks, 9 weeks, 6 months, and 12 months after randomization. Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 (by telephone calls), and weeks 4 and 9 as well as months 6 and 12 (by clinic visits). Withdrawal symptoms will also be assessed by the nurses during their weekly calls. Trials previously conducted with bupropion involved young healthy smokers. The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS. 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 an ACS.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

National Heart Foundation of Bangladesh, Dhaka, Bangladesh

Hopital Laval, Quebec G1V 4G5, Canada

Centre for Chronic Disease Control, New Delhi, India

InterActive Research and Development, Karachi, Pakistan

University Hospital F. Bourguiba, Sousse, Tunisia

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

Parkview Medcial Center, Pueblo, Colorado 81003, United States

Isfahan Cardiovascular Research Centre, Isfahan, Iran, Iran, Islamic Republic of

Central Maine Medical Center, Lewiston, Maine 04240, United States

St. Boniface General Hospital, Winnipeg, Manitoba, Canada

Victoria General Hospital, Winnipeg, Manitoba R3T 2E8, Canada

Bay Regional Medical Center, Bay City, Michigan, United States

New Brunswick Heart Centre, Saint Johns, New Brunswick, Canada

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

Valley Regional Hospital, Kentville, Nova Scotia, Canada

Schuster Cardiology, Kettering, Ohio 45429, United States

Southwest Cardiology, Kettering, Ohio 45429, United States

DVA Medical Center, Oklahoma City, Oklahoma 73104, United States

The Ottawa Hospital, General Campus, Ottawa, Ontario, Canada

St. Michael's Hospital, Toronto, Ontario, Canada

Advanced Cardiology Specialists, Scranton, Pennsylvania 18501, United States

Hopital de la Cite de la Sante, Laval, Quebec H7M 3L9, Canada

CHA Hotel-Dieu de Levis, Levis, Quebec, Canada

Hopital Sacre-Coeur de Montreal, Montreal, Quebec, Canada

Hotel-Dieu, Montreal, Quebec, Canada

Montreal General Hospital, Montreal, Quebec, Canada

SMBD- Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada

Hopital Fleurimont, Sherbrooke, Quebec J1H 5N4, Canada

CSSS de Sorel-Tracy, Sorel, Quebec, Canada

CSSS de la Region de Thetford, Thetford Mines, Quebec, Canada

Saskatchewan Drug Research Institute, Saskatoon, Saskatchewan S7N 0W8, Canada

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

Additional Information

Starting date: December 2005
Last updated: April 10, 2015

Page last updated: August 23, 2015

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