A randomised, controlled trial in primary care of a nicotine replacement therapy (NRT) assisted cessation intervention amongst adult smokers with established vascular disease to confirm effectiveness, safety and genetic influences

ISRCTN	ISRCTN27140757
DOI	https://doi.org/10.1186/ISRCTN27140757
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr Paul Aveyard
Scientific

General Practice Research Group
Department of Clinical Pharmacology
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 2BE
United Kingdom

Phone	+44 (0)1865 228484
Email	paul.aveyard@clinpharm.ox.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	RESCINDING
Study hypothesis	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Condition	Cardiovascular disease
Intervention	Nicotine replacement therapy in the form of patches versus placebo
Intervention type	Other
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/07/2005
Overall study end date	30/06/2008
Reason abandoned (if study stopped)	TRIAL TERMINATED BEFORE RECRUITMENT started due to lack of funding

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	2400
Participant inclusion criteria	All smokers (self-report ≥10 cigarettes per day) aged 18 years and over who wish to stop with (at least) one of the following diagnoses: 1. Ischaemic Heart Disease: i. Stable Angina, clinically or exercise electrocardiogram (ECG) diagnosed ii. Myocardial infarction more than 2 months previously with recovery uncomplicated by any rhythm disturbances other than atrial fibrillation 2. Cerebrovascular disease: No exclusions 3. Peripheral vascular disease: No exclusions
Participant exclusion criteria	1. Patients the GP, for whatever reason, does not wish to include 2. Known skin hypersensitivity to nicotine, plasters or widespread active eczema/psoriasis or other skin conditions that would restrict patch application 3. Pregnant or breast feeding women or those who are not using reliable contraceptive methods 4. Phaeochromocytoma/Hyperthyroidism and severe renal and/or hepatic impairment 5. Severe (life threatening) arrhythmia 6. Command of English (+/- interpreter) or impairment of faculties does not allow informed consent
Recruitment start date	01/07/2005
Recruitment end date	30/06/2008

General Practice Research Group

Oxford
OX2 2BE
United Kingdom

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 270000
Email	research.services@admin.ox.ac.uk
Website	http://www.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Research council

Medical Research Council (MRC) (Grant number: G0200247)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan