EUCTR2009-012451-18-NLActive, not recruitingNot Applicable
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)
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 1,060
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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)
- •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
Exclusion Criteria
- •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
Investigators
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