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

Completed

• Conditions: Cardiovascular disease; Circulatory System; Nicotine replacement therapy

• Registration Number: ISRCTN27140757
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration.