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ISRCTN
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ISRCTN75356261
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ClinicalTrials.gov identifier
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NCT00689611
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Public title
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Zyban as an effective smoking cessation aid for patients following acute coronary syndrome (ACS): The ZESCA trial
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Scientific title
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Zyban as an effective smoking cessation aid for patients following acute coronary syndrome (ACS): a randomised controlled trial
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Acronym
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ZESCA
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Serial number at source
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MCT-64989
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Study hypothesis
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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
Please note that as of 04/03/2009 the anticipated end date in this record was amended; the initial end date at the time of registration was:
Initial anticipated end date: 30/09/2007
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Lay summary
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Ethics approval
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Research Ethics Committee, Jewish General Hospital, Montreal gave approval on the 24th January 2005.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Acute coronary syndrome
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2005
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Anticipated end date
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01/04/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1500
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Interventions
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Sustained-release bupropion versus placebo.
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Primary outcome measure(s)
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Smoking abstinence rates at 12 months post-ACS.
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Secondary outcome measure(s)
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1. Cumulative side effects and safety of bupropion at 9 weeks
2. Composite clinical events (unstable angina, myocardial infarction [MI], seizure, death)
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64989)
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Trial website
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Publications
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Contact name
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Dr
Mark Jeffrey
Eisenberg
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Address
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Cardiology and Clinical Epidemiology
Sir Mortimer B Davis Jewish General Hospital
McGill University
3755 Cote Ste Catherine Road/Suite A118
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City/town
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Montreal, Quebec
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Zip/Postcode
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H3T 1E2
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Country
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Canada
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Tel
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+1 514 340 8222 ext. 3564
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Fax
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+1 514 340 7564
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Email
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mark.eisenberg@mcgill.ca
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Sponsor
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Sir Mortimer B Davis Jewish General Hospital (Canada)
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Address
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3755 Côte Ste Catherine
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City/town
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Montreal, Quebec
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Zip/Postcode
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H3T 1E2
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Country
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Canada
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Tel
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+1 514 340 8222
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Fax
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+1 514 340 7564
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Email
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meisenberg@epid.jgh.mcgill.ca
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Sponsor website:
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http://www.cihr-irsc.gc.ca
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Date applied
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29/07/2005
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Last edited
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04/03/2009
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Date ISRCTN assigned
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29/07/2005
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