Condition category
Circulatory System
Date applied
29/07/2005
Date assigned
29/07/2005
Last edited
23/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cihr-irsc.gc.ca

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

Federal/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

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00689611

Publication summary

Publication citations

Additional files

Editorial Notes

On 04/03/2009 the overall trial end date was changed from 30/09/2007 to 01/04/2010.