EUROACTION PLUS: Intensive smoking intervention (Varenicline) during a preventive cardiology programme for patients with established atherosclerotic disease, people at high cariovascular risk and their families - EUROACTION PLUS INTENSIVE SMOKING INTERVENTION (VARENICLINE)
- Conditions
- Current cigarette smokers with coronary or other atherosclerotic disease or people at high risk of developing cardiovascular diseaseMedDRA version: 12.1Level: LLTClassification code 10053325Term: Smoking cessation therapy
- Registration Number
- EUCTR2009-012451-18-NL
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1060
1 Vascular patients and partners
All patients, men and women 18 years of age or older but less than 80 years, with a new or recurrent diagnosis of coronary or other atherosclerotic vascular disease, and who are continuing to smoke, will be eligible for the programme.
Patients may fulfill more than one of thefollowing criteria:
1) Acute myocardial infarction (STEMI or NSTEMI)
2) Unstable angina
3) Stable angina pectoris
4) Elective revascularisation:
- coronary artery by-pass graft (CABG)
- percutaneus transluminal angioplasty (PTCA)
5)Stroke
6)Transient iscaemic attack (TIA)
7)Peripheral vascular disease (PVD)
The partners of all recruited vascular patients will also be identified and invited to participate in the programme.
2. High-risk patients and partners
All high risk people who meet the following inclusion criteria: Men and women, 50 years of age or older, but less than 80 years, who are smokers and either
1) 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
2) have been treated with antihypertensive and/or lipid-lowering therapies in the last year; or
3) have diabetes mellitus diagnosed within the last 3 years.
The partners of all recruited high risk patients will also be identified and invited to participate in the programme.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Vascular patients:
- 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.
High risk people:
- history of coronary heart disease
- severe heart failure
- severe physical disability
- impaired cognitive function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method