Euroaction plus intensive smoking intervention (varenicline)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 212

Inclusion Criteria

1. Vascular patients and partners;All patients with a medical diagnosis of coronary or other atherosclerotic disease (see below), and who have been smoking 5 or more cigarettes per day within the last month and are willing to make a quit attempt, 18 years of age or older, but less than 80 years, will be eligible for the comprehensive preventive cardiology programme, including smoking cessation service with Varenicline.;i) Acute myocardial infarction (STEMI or NSTEMI)
ii) Unstable angina
iii) Stable angina pectoris
iv) Elective revascularisation: coronary artery bypass graft (CABG), percutaneus coronary internvention (PCI)
v) Stroke
vi) Transient ischaemic attack (TIA)
vii) Peripheral vascular disease (PVD);The partners of all recruited coronary patients will also be identified and invited to participate in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including Varenicline.;2. High*risk people and partners;All high risk people - smokers who have been smoking 5 or more cigarettes per day within the last month and willing to make a quit attempt, who meet the inclusion criteria (see below) will be eligible for the preventive cardiology programme, including smoking cessation service with Varenicline: ;Men and women, 50 years of age or older, but less than 80 years, who are smokers willing to make a quit attempt and either
i) are newly identified high multifactorial risk individuals: CVD risk equal or greater than 5% over 10 years (now or projected to age 60 years), according to the HeartScore risk estimation system; or
ii) have been treated with antihypertensive and/or lipid*lowering therapies; or
iii) have diabetes mellitus. ;The partners of all recruited high risk patients will also be identified and invited to participate
in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including Varenicline.

Exclusion Criteria

Patients with coronary artery disease or atherosclerotic vascular disease
* severe heart failure
* severe physical disability
* impaired cognitive function
* patients with acute coronary syndromes, with or without revasularisation, will not be included
in the study until 2 weeks has elapsed following their coronary event.
- hypersensitivity to Varenicline (active substance or to any of the inactive ingredients)
- history of suicidal attempt
- history of psychosis
- bipolar disorders
- panic disorders
- epilepsy
- history of alcohol dependence;High-risk people:;* history of coronary or other atherosclerotic disease
* severe heart failure
* severe physical disability
* impaired cognitive function
- hypersensitivity to Varenicline (active substance or to any of the inactive ingredients)
- history of suicidal attempt within the last 10 years
- history of psychosis
- bipolar disorders
- panic disorders
- epilepsy
- history of alcohol dependence

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study will be the 7day point (period) prevalence of<br /><br>non-smoking at 16 weeks. The smoking cessation will be validated by breath CO <<br /><br>10 ppm. Patients will be classified as non-smokers if they are not smoking in<br /><br>the week prior to their 16 week assessment even if they have relapsed several<br /><br>times in the intervening period. If they are smoking in that same week, and/or<br /><br>breath CO is raised, they will be classified as smokers. The primary outcome is<br /><br>the prevalence of non-smokers in intervention compared to usual care.<br /><br>After more than one year after the study, the longterm effects of the<br /><br>intervention will be assessed by repeating the calculation of the non-smoking<br /><br>prevalence.</p><br>

Secondary Outcome Measures