A comparison of Nicotine Replacement Therapy and Nicotine Replacement Therapy combined with the Minimal Intervention Strategy for smoking cessation in cardiovascular outpatients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22579361

Enrollment

365

Registered

2005-09-13

Start date

2001-09-01

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Cardiovascular disease Circulatory System Coronary artery disease, peripheral arterial disease

Interventions

In the experimental arm: Nicotine Replacement Therapy (patches) and The Minimal Intervention Strategy (short behavioural counselling) In the control arm: only Nicotine Replacement The

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients who attend the cardiological or vascular surgical outpatients clinic, have a diagnosis of atherosclerotic cardiac or arterial disease and who smoked until the cardiac event more than 5 cigarettes per day, will be included.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction in the month prior to randomisation 2. Unstable angina 3. Serious arrhythmia 4. Recent stroke 5. Skin allergy complicating the use of nicotine patches

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is smoking cessation at 12 months follow-up, as indicated by patient self-report and objectivated by urine cotinine levels.	—

Secondary

Measure	Time frame
Secondary endpoints are: 1. Changes in cognitions and smoking behaviour 2. Change in quality of life (generic and disease specific quality of life) 3. Adherence to NRT 4. Evaluation of the intervention	—

Countries

Netherlands

Outcome results

None listed

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