Contact information
Type
Scientific
Primary contact
Dr Mark Jeffrey Eisenberg
ORCID ID
Contact details
Cardiology and Clinical Epidemiology
Sir Mortimer B Davis Jewish General Hospital
McGill University
3755 Cote Ste Catherine Road/Suite A118
Montreal
Quebec
H3T 1E2
Canada
+1 (0)514 340 8222 ext. 3564
mark.eisenberg@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00689611
Protocol/serial number
MCT-64989
Study information
Scientific title
Zyban as an effective smoking cessation aid for patients following acute coronary syndrome (ACS): a randomised controlled trial
Acronym
ZESCA
Study hypothesis
Nicotine dependence in patients with a recent enzyme-positive acute coronary syndrome:
1. To examine the impact of sustained-release bupropion on smoking abstinence rates at one year following an enzyme-positive acute coronary syndrome
2. To examine the safety of sustained-release bupropion in patients following an ACS
Ethics approval
Research Ethics Committee, Jewish General Hospital, Montreal, 24/01/2005
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute coronary syndrome
Intervention
Sustained-release bupropion versus placebo.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bupropion
Primary outcome measure
Smoking abstinence rates at 12 months post-ACS
Secondary outcome measures
1. Cumulative side effects and safety of bupropion at 9 weeks
2. Composite clinical events (unstable angina, myocardial infarction [MI], seizure, death)
Overall trial start date
01/09/2005
Overall trial end date
01/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age: greater than or equal to 18 years
2. Active smoker (greater than or equal to 10 cigarettes per day, on average) for the past year
3. Suffered an ACS and planned hospitalization of greater than or equal to 48 hours
ACS is defined as positive Troponin T, Troponin I, or CK-MB levels and greater than or equal to one of the following:
3.1. Ischaemic symptoms (i.e. typical chest pain) for at least 20 minutes
3.2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression)
3.3. Development of pathological Q waves on the ECG
Note: If patient is to undergo percutaneous coronary intervention (PCI) and/or coronary artery bypass graft surgery (CABG), they are still eligible to be enrolled.
4. Motivated to quit smoking
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1500
Participant exclusion criteria
1. Current seizure disorder, history of seizures, or predisposition to seizures (e.g. history of brain tumour, severe head trauma, or stroke)
2. Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinalone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)
3. History of anorexia nervosa or bulimia
4. Current use of Wellbutrin or any other medications that contain bupropion
5. Pregnancy or lactation
Recruitment start date
01/09/2005
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Canada
Trial participating centre
McGill University
Montreal, Quebec
H3T 1E2
Canada
Sponsor information
Organisation
Sir Mortimer B Davis Jewish General Hospital (Canada)
Sponsor details
3755 Côte Ste Catherine
Montreal
Quebec
H3T 1E2
Canada
+1 (0)514 340 8222
meisenberg@epid.jgh.mcgill.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00689611
Publication list
1. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24440324 (added 11/04/2019)
2. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25326910 (added 11/04/2019)