Trial Outcomes & Findings for Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery (NCT NCT02918500)

Last Updated: 2022-01-05

Results Overview

To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)

Results posted on

2022-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants will receive 3 weeks of inactive NRT patches.	Active Participants will receive 3 weeks of active NRT patches Nicoderm Patch: Nicotine replacement therapy patch
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=2 Participants Participants will receive 3 weeks of inactive NRT patches.	Active n=2 Participants Participants will receive 3 weeks of active NRT patches Nicoderm Patch: Nicotine replacement therapy patch	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants	70 years n=7 Participants	68.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)

Population: Study terminated due to recruitment challenges. Only 4 participants were recruited and therefore there was not enough data to warrant analysis.

To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the time of surgery and each follow up visit (1 & 6 months post-op)

Population: Due to a small sample size recruited for this trial, the follow up data was not assessed within either group

Measured by the perceived stress scale (PSS-14)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at the 1 and 6 month post-op follow up visits

Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Pipe

University of Ottawa Heart Institute

Phone: 613-696-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place