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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27140757
Enrollment
2400
Registered
2005-04-01
Start date
2005-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Circulatory System Nicotine replacement therapy

Interventions

Nicotine replacement therapy in the form of patches versus placebo

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration.

Secondary

MeasureTime frame
Not provided at time of registration.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026