Condition category
Circulatory System
Date applied
19/01/2005
Date assigned
01/04/2005
Last edited
03/03/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Aveyard

ORCID ID

Contact details

General Practice Research Group
Department of Clinical Pharmacology
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 2BE
United Kingdom
+44 (0)1865 228484
paul.aveyard@clinpharm.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

RESCINDING

Study hypothesis

Not provided at time of registration.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular disease

Intervention

Nicotine replacement therapy in the form of patches versus placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/07/2005

Overall trial end date

30/06/2008

Reason abandoned

TRIAL TERMINATED BEFORE RECRUITMENT started due to lack of funding

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

2400

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

General Practice Research Group
Oxford
OX2 2BE
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (Grant number: G0200247)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes