Current cigarette smokers with coronary or other atherosclerotic disease or people at high risk of developing cardiovascular disease Level: LLT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Varenicline Tartrate
CAS Number: 249296-44-4
Other descriptive name: 7,8,9,10-tetrahydro-6,10-met
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate whether VARENICLINE prescribed to patients enrolled to a preventive cardiology programme can achieve faster, more effective smoking cessation in patients with coronary or other atherosclerotic disease, people at high cardiovascular risk and their partners in every day clinical practice.;Secondary Objective: Secondary research questions: (i) Number of smoking relapses in intervention and usual care. Smoking relapse is defined as to “the time to last cigarette from the start of Varenicline” (ii) Compliance with varenicline and all other drug therapies. (iii) Mean number of cigarettes being smoked at baseline and 16 weeks (in those who are continuing smoking). (iv) Side effects of varenicline (v) Proportions of patients in whom varenicline is withdrawn and the medical reasons given. (vi) Proportions of patients achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: a) smoking habit (self reported, breath carbon monoxide {CO}, Fagerstrom Test for Nicotine Dependence (FTND)) b) diet/ nutrition (self reported, food habit questionnaire) c) physical activity (self reported, step counter, Chester step test, DASI physical activity questionnaire) d) overweight/ obesity (body mass index (BMI), waist circumference) e) diab;Primary end point(s): The primary endpoint of the study will be the 7-day point (period) prevalence of non-smoking at 16 weeks . The smoking cessation will be validated by breath CO < 10 ppm. Patients will be classified as non-smokers if they are not smoking in the week prior to their 16 week assessment even if they have relapsed several times in the intervening period. If they are smoking in that same week, and/or breath CO is raised, they will be classified as smokers. The primary endpoint is the prevalence of non-smokers in intervention compared to usual care. | — |
Countries
Netherlands, Spain, United Kingdom
Outcome results
None listed