Trial Outcomes & Findings for Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial (NCT NCT00689611)
NCT ID: NCT00689611
Last Updated: 2015-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
392 participants
Primary outcome timeframe
12 months
Results posted on
2015-04-23
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo for 9 weeks.
|
Bupropion
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 Study
STARTED
|
200
|
192
|
|
Overall Study
COMPLETED
|
159
|
146
|
|
Overall Study
NOT COMPLETED
|
41
|
46
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo for 9 weeks.
|
Bupropion
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 Study
Death
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
|
Overall Study
Lost to Follow-up
|
27
|
28
|
Baseline Characteristics
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
Baseline characteristics by cohort
| Measure |
Placebo
n=200 Participants
participants received placebo for 9 weeks.
Placebo: Placebo
|
Bupropion
n=192 Participants
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
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Pakistan
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
101 participants
n=5 Participants
|
96 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Iran, Islamic Republic of
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
India
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
No. of years smoked
|
32.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
No. of cigarettes/day (past year)
|
23.2 cigarettes/day
STANDARD_DEVIATION 10.4 • n=5 Participants
|
23.2 cigarettes/day
STANDARD_DEVIATION 10.8 • n=7 Participants
|
23.2 cigarettes/day
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Index admission was for ST-segment elevation myocardial infarction [STEMI]
|
133 participants
n=5 Participants
|
121 participants
n=7 Participants
|
254 participants
n=5 Participants
|
|
Cardiac catheterization during index admission
|
136 participants
n=5 Participants
|
128 participants
n=7 Participants
|
264 participants
n=5 Participants
|
|
Percutaneous coronary intervention during index admission
|
104 participants
n=5 Participants
|
93 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Coronary artery bypass graft during index admission
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Placebo
n=194 Participants
Participants received placebo for 9 weeks.
|
Bupropion
n=183 Participants
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
|
|---|---|---|
|
Smoking Abstinence
|
32.0 percentage of participants
|
37.2 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsAll 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)
Outcome measures
| Measure |
Placebo
n=200 Participants
Participants received placebo for 9 weeks.
|
Bupropion
n=192 Participants
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
|
|---|---|---|
|
Composite Major Adverse Cardiovascular Events (MACE)
|
11.0 percentage of participants
|
13.0 percentage of participants
|
Adverse Events
Placebo
Serious events: 37 serious events
Other events: 48 other events
Deaths: 0 deaths
Bupropion
Serious events: 34 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=200 participants at risk
Participants received placebo for 9 weeks.
|
Bupropion
n=192 participants at risk
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
|
|---|---|---|
|
General disorders
Death
|
3.0%
6/200 • Number of events 6
|
4.7%
9/192 • Number of events 9
|
|
Cardiac disorders
Myocardial Infarction
|
2.5%
5/200 • Number of events 5
|
2.6%
5/192 • Number of events 5
|
|
Cardiac disorders
Unstable Angina
|
5.5%
11/200 • Number of events 11
|
6.2%
12/192 • Number of events 12
|
|
Vascular disorders
Stroke
|
0.50%
1/200 • Number of events 1
|
0.00%
0/192
|
|
Psychiatric disorders
Psychiatric event
|
0.50%
1/200 • Number of events 1
|
1.0%
2/192 • Number of events 2
|
|
General disorders
Other
|
8.5%
17/200 • Number of events 17
|
4.7%
9/192 • Number of events 9
|
Other adverse events
| Measure |
Placebo
n=200 participants at risk
Participants received placebo for 9 weeks.
|
Bupropion
n=192 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
18.0%
36/200 • Number of events 36
|
22.4%
43/192 • Number of events 43
|
|
General disorders
Dry mouth
|
9.0%
18/200 • Number of events 18
|
13.5%
26/192 • Number of events 26
|
|
General disorders
Dizziness
|
8.5%
17/200 • Number of events 17
|
7.8%
15/192 • Number of events 15
|
|
General disorders
Dysgeusia
|
6.5%
13/200 • Number of events 13
|
8.3%
16/192 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
6.0%
12/200 • Number of events 12
|
7.3%
14/192 • Number of events 14
|
|
General disorders
Dream abnormality
|
8.5%
17/200 • Number of events 17
|
3.6%
7/192 • Number of events 7
|
|
General disorders
Pruritus
|
4.0%
8/200 • Number of events 8
|
2.6%
5/192 • Number of events 5
|
Additional Information
Dr. Mark J. Eisenberg
Divisions of Cardiology and Clinical Epidemiology, Jewish General Hospital/McGill University
Phone: 514.340.8222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60