EUROACTION PLUS intensive smoking intervention (varenicline)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1060

Inclusion Criteria

Vascular patients and partners:
1. Patients with a medical diagnosis of coronary or other atherosclerotic disease:
1.1. Acute myocardial infarction (ST segment elevation myocardial infarction [STEMI] or non-ST segment elevation myocardial infarction [NSTEMI])
1.2. Unstable angina
1.3. Stable angina pectoris
1.4. Elective revascularisation: coronary artery bypass graft (CABG), percutaneous transluminal angioplasty (PTCA)
1.5. Stroke
1.6. Transient ischaemic attack (TIA)
1.7. Peripheral vascular disease (PVD)
2. Have been smoking 5 or more cigarettes per day within the last month
3. Willing to make a quit attempt
4. Aged 18 years of age or older, but less than 80 years, either sex

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.

High-risk people and partners:
1. Have been smoking 5 or more cigarettes per day within the last month
2. Willing to make a quit attempt
3. Men and women, 50 years of age or older, but less than 80 years, either sex
4. Either:
4.1. 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
4.2. Have been treated with antihypertensive and/or lipid-lowering therapies; or
4.3. 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

Vascular patients:
1. Severe heart failure
2. Severe physical disability
3. Impaired cognitive function
4. 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
5. Hypersensitivity to varenicline (active substance or to any of the inactive ingredients)
6. History of suicidal attempt
7. History of psychosis
8. Bipolar disorders
9. Panic disorders
10. Epilepsy
11. History of alcohol dependence

High-risk people:
1. History of coronary or other atherosclerotic disease
2. Severe heart failure
3. Severe physical disability
4. Impaired cognitive function
5. Hypersensitivity to varenicline (active substance or to any of the inactive ingredients)
6. History of suicidal attempt within the last 10 years
7. History of psychosis
8. Bipolar disorders
9. Panic disorders
10. Epilepsy
11. History of alcohol dependence

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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