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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00689611
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Mark Eisenberg, McGill University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Coronary Syndrome
Myocardial Infarction
Smoking
Interventions Drug: Bupropion HCl ER
Drug: Placebo
Enrollment 392
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Bupropion
Hide Arm/Group Description Participants received placebo for 9 weeks.

Participants received bupropion for 9 weeks.

Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks.

Period Title: Overall Study
Started 200 192
Completed 159 146
Not Completed 41 46
Reason Not Completed
Death             6             9
Withdrawal by Subject             8             9
Lost to Follow-up             27             28
Arm/Group Title Placebo Bupropion Total
Hide Arm/Group Description

participants received placebo for 9 weeks.

Placebo: Placebo

participants received bupropion for 9 weeks.

Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks

Total of all reporting groups
Overall Number of Baseline Participants 200 192 392
Hide Baseline Analysis Population Description
All enrolled participants were included in the baseline analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 192 participants 392 participants
53.4  (10.3) 54.5  (10.4) 53.9  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
Female
34
  17.0%
31
  16.1%
65
  16.6%
Male
166
  83.0%
161
  83.9%
327
  83.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
United States 35 33 68
Pakistan 18 18 36
Canada 101 96 197
Iran, Islamic Republic of 31 31 62
Tunisia 6 4 10
India 9 10 19
No. of years smoked  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 192 participants 392 participants
32.6  (11.9) 33.2  (13.0) 32.9  (12.4)
No. of cigarettes/day (past year)  
Mean (Standard Deviation)
Unit of measure:  Cigarettes/day
Number Analyzed 200 participants 192 participants 392 participants
23.2  (10.4) 23.2  (10.8) 23.2  (10.6)
Index admission was for ST-segment elevation myocardial infarction [STEMI]  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
133 121 254
Cardiac catheterization during index admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
136 128 264
Percutaneous coronary intervention during index admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
104 93 197
Coronary artery bypass graft during index admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 192 participants 392 participants
15 10 25
1.Primary Outcome
Title Smoking Abstinence
Hide Description

The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.

The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bupropion
Hide Arm/Group Description:
Participants received placebo for 9 weeks.

Participants received bupropion for 9 weeks.

Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks

Overall Number of Participants Analyzed 194 183
Measure Type: Number
Unit of Measure: percentage of participants
32.0 37.2
2.Secondary Outcome
Title Composite Major Adverse Cardiovascular Events (MACE)
Hide Description

All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.

Composite MACE (death, myocardial infarction, unstable angina)

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bupropion
Hide Arm/Group Description:
Participants received placebo for 9 weeks.

Participants received bupropion for 9 weeks.

Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks

Overall Number of Participants Analyzed 200 192
Measure Type: Number
Unit of Measure: percentage of participants
11.0 13.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Bupropion
Hide Arm/Group Description Participants received placebo for 9 weeks.

Participants received bupropion for 9 weeks.

Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks

All-Cause Mortality
Placebo Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Bupropion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/200 (18.50%)      34/192 (17.71%)    
Cardiac disorders     
Myocardial Infarction   5/200 (2.50%)  5 5/192 (2.60%)  5
Unstable Angina   11/200 (5.50%)  11 12/192 (6.25%)  12
General disorders     
Death  [1]  6/200 (3.00%)  6 9/192 (4.69%)  9
Other  [2]  17/200 (8.50%)  17 9/192 (4.69%)  9
Psychiatric disorders     
Psychiatric event  [3]  1/200 (0.50%)  1 2/192 (1.04%)  2
Vascular disorders     
Stroke   1/200 (0.50%)  1 0/192 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Deaths due to: coronary dissection, cardiac arrest (2), multisystem organ failure post-CABG, complications related to duodenal perforation and recurrent septic shock, ischemic event in the bowel or spinal cord.
[2]
Specific adverse event terms by treatment group are unknown.
[3]
Includes delirium, hallucination, and suicidal ideation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo Bupropion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/200 (24.00%)      58/192 (30.21%)    
Gastrointestinal disorders     
Constipation   12/200 (6.00%)  12 14/192 (7.29%)  14
General disorders     
Dry mouth   18/200 (9.00%)  18 26/192 (13.54%)  26
Dizziness   17/200 (8.50%)  17 15/192 (7.81%)  15
Dysgeusia   13/200 (6.50%)  13 16/192 (8.33%)  16
Dream abnormality   17/200 (8.50%)  17 7/192 (3.65%)  7
Pruritus   8/200 (4.00%)  8 5/192 (2.60%)  5
Nervous system disorders     
Insomnia   36/200 (18.00%)  36 43/192 (22.40%)  43
Indicates events were collected by systematic assessment
Relatively high number who withdrew or were lost to follow-up (22.2%), but within expectations for smoking cessation trials; Relatively small numbers of serious adverse events occurred, limiting power to examine secondary safety end points.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark J. Eisenberg
Organization: Divisions of Cardiology and Clinical Epidemiology, Jewish General Hospital/McGill University
Phone: 514.340.8222 ext 3564
EMail: mark.eisenberg@mcgill.ca
Layout table for additonal information
Responsible Party: Mark Eisenberg, McGill University
ClinicalTrials.gov Identifier: NCT00689611    
Other Study ID Numbers: ZESCA 9197
ISRCTN75356261
First Submitted: May 30, 2008
First Posted: June 3, 2008
Results First Submitted: December 11, 2013
Results First Posted: April 23, 2015
Last Update Posted: April 23, 2015