Zyban as an effective smoking cessation aid for patients following acute coronary syndrome (ACS): The ZESCA trial
| ISRCTN | ISRCTN75356261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75356261 |
| ClinicalTrials.gov number | NCT00689611 |
| Secondary identifying numbers | MCT-64989 |
- Submission date
- 29/07/2005
- Registration date
- 29/07/2005
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark Jeffrey Eisenberg
Scientific
Scientific
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
| Phone | +1 (0)514 340 8222 ext. 3564 |
|---|---|
| mark.eisenberg@mcgill.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Zyban as an effective smoking cessation aid for patients following acute coronary syndrome (ACS): a randomised controlled trial |
| Study acronym | ZESCA |
| Study objectives | 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(s) | Research Ethics Committee, Jewish General Hospital, Montreal, 24/01/2005 |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| Intervention | Sustained-release bupropion versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2005 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
McGill University
Montreal, Quebec
H3T 1E2
Canada
H3T 1E2
Canada
Sponsor information
Sir Mortimer B Davis Jewish General Hospital (Canada)
Hospital/treatment centre
Hospital/treatment centre
3755 Côte Ste Catherine
Montreal, Quebec
H3T 1E2
Canada
| Phone | +1 (0)514 340 8222 |
|---|---|
| meisenberg@epid.jgh.mcgill.ca | |
| Website | http://www.cihr-irsc.gc.ca |
"ROR" |
https://ror.org/056jjra10 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/03/2014 | 11/04/2019 | Yes | No |
| Results article | results | 01/03/2014 | 11/04/2019 | Yes | No |
Editorial Notes
11/04/2019: Publication reference added.
04/03/2009: The overall trial end date was changed from 30/09/2007 to 01/04/2010.
