Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000572460
Ethics application status
Approved
Date submitted
5/11/2007
Date registered
6/11/2007
Date last updated
6/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Nicotine replacement thrapy as a secondary prevention strategy in post-operative coronary bypass patients
Scientific title
An examination of the effectiveness of transdermal nicotine replacment therapy as a secondary prevention strategy in patients admitted to hospital for coronary artery bypass grafting
Universal Trial Number (UTN)
Trial acronym
NRT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking 2526 0
Condition category
Condition code
Cardiovascular 2622 2622 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transdermal nicotine patch. 10 week programe of nicotine patch starting at 21mg for 6 weeks, 14 mg for 2 weeks, 7mg of 2 weeks.
Transdermal nicotine patch contains nicotine which is absorbed through the skin.
Intervention code [1] 2255 0
Treatment: Drugs
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 3533 0
6 month abstinence rates,
Timepoint [1] 3533 0
6 month following bypass surgery & initiation of intervention
Secondary outcome [1] 5913 0
withdrawal symptoms
Timepoint [1] 5913 0
1 wk, 4 wks, 3 mths, 6 mths
Secondary outcome [2] 5914 0
adverse effects
Timepoint [2] 5914 0
1 wk, 4 wks, 3 mths, 6 mths

Eligibility
Key inclusion criteria
Current smoker, admitted to hospital for coronary artery bypass grafting.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent myocardial infarction ( within 3mths prior to recruitment). Suffer from unstable angina. Has suffered a cerebrovascular accident (CVA). Hypersensitivity to nicotine, menthol or adhesive tapes. History of substance abuse in the previous 12mts.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be assessed by the pre-operative cardiac education nurse for inclusion or exclusion into the study. Following identification for inclusion the pre-op education nurse will randomly remove an envelope from a box provided, this envelope will have an ID Number printed on it which will become the participants ID No for the study. Participants will be required to complete the questionnaires inside the envelope and at various stages throughout the study process . Participants will be provided with an information sheet which outlines the studies purpose and aims. Participants will be required to sign a consent form in the presence of the pre-op education nurse who will also witness this form. ID numbers will be used on all documentation and drugs thorughout the trial process to assure anonymity and confidentiality of data. The participant (if in the intervention group) will begin drug (NRT) treatment following surgery and transfer to the cardiac step-down unit (approximately 24 hrs or more following surgery).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participant ID numbers will be achieved by a computer generated randomisation sequence using Microsoft Excel. The envelopes that contain the questionnaires will have the ID number printed on the exterior. These envelopes will be placed within a box for the cardiac pre-op education nurse to randomly remove during recruitment. The ID number of which has already been randomised to either the control or intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 319 0
5000

Funding & Sponsors
Funding source category [1] 2767 0
University
Name [1] 2767 0
GlaxoSmithKline
Country [1] 2767 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of General Practice
North Terace
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 2500 0
Commercial sector/Industry
Name [1] 2500 0
GlaxoSmithKline
Address [1] 2500 0
GlaxoSmithKline
Consumer Healthcare
82 Hughes Avenue
Ermington
NSW 2115
Country [1] 2500 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4689 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 4689 0
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 4689 0
Australia
Date submitted for ethics approval [1] 4689 0
Approval date [1] 4689 0
24/09/2007
Ethics approval number [1] 4689 0
070911

Summary
Brief summary
The purpose of this study is to examine the post operative efficacy and safety of NRT initiated in patients admitted to hospital for coronary artery bypass surgery. We hypothesise that commencing NRT in the immediate post operative phase will be well tolerated by patients, lead to fewer withdrawal symptoms and greater quit rates at 6 months. This pilot randomised control trial is expected to validate the feasibility of conducting a larger scale multi-centre trial that will generate evidence to support the use of NRT as an inpatient initiated secondary prevention strategy in post-operative bypass patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28162 0
Address 28162 0
Country 28162 0
Phone 28162 0
Fax 28162 0
Email 28162 0
Contact person for public queries
Name 11319 0
Fiona May
Address 11319 0
Discipline of General Practice
University of Adelaide
North Terrace
Adelaide
South Australia 5005
Country 11319 0
Australia
Phone 11319 0
0413 683 693
Fax 11319 0
08 8303 3511
Email 11319 0
[email protected]
Contact person for scientific queries
Name 2247 0
Fiona May
Address 2247 0
Discipline of General Practice
North Terrace
Adelaide
South Australia 5005
Country 2247 0
Australia
Phone 2247 0
08 8303 3460
Fax 2247 0
08 8303 3511
Email 2247 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.