A practical demonstration project in 5 European countries to show that intensive smoking intervention during a preventive cardiovascular risk management programme for patients with cardiovascular (CVD) or other atherosclerotic disease, asymptomatic…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study will be the 7day 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 outcome is
the prevalence of non-smokers in intervention compared to usual care.
After more than one year after the study, the longterm effects of the
intervention will be assessed by repeating the calculation of the non-smoking
prevalence.
Secondary outcome
The secondary outcomes are:
(i) Number of smoking relapses in intervention.
(ii) Adverse effects
(iii) Proportions of patients achieving European and national lifestyle, risk
factors and therapeutic targets for cardiovascular disease prevention:
a) smoking (self reported, breath carbon monoxide [CO]
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) diabetes (known/new, fasting and random plasma glucose, glycated haemoglobin
(Hb A1c) in patients with diabetes)
f) blood pressure
g) total cholesterol, high-density lipoprotein (HDL) cholesterol,
triglycerides, calculated low-density
lipoprotein (LDL) cholesterol)
h) smoking cessation drug therapies:
- Varenicline
- Nicotine replacement therapy
- Bupropion hydrochloride
i) cardioprotective drug therapies
iv) Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS),
Quality of Life (EQ-5D).
After more than one year after the study, the longterm effecs on the outcomes
a, b, c (only DASI questionnaire), d, f, i, en iv.
Background summary
There is substantial evidence that professional lifestyle intervention on
smoking, diet and physical activity together with control of cardiovascular
risk factors can reduce the risk of cardiovascular disease. The recent
Euroaction study showed in 2002 beneficial effects of a comprehensive
cardiovascular risk management programme on achieving targets of European
guidelines for cardiovascular disease prevention. However, a considerable
proportion of coronary and high risk patients remained smokers at the end of
the Euroaction programme, leaving considerable room for improvement.
Therefore, a pragmatic trial is proposed to demonstrate whether Varenicline can
achieve more effective smoking cessation in high risk patients within a
comprehensive cardiovascular risk prevention programme.
Study objective
A practical demonstration project in 5 European countries to show that
intensive smoking intervention during a preventive cardiovascular risk
management programme for patients with cardiovascular (CVD) or other
atherosclerotic disease, asymptomatic individuals at high risk of developing
CVD, and their partners, enrolled to a preventive cardiovascular risk
management programme in primary care is effective for smoking cessation in
every day clinical practice.
Study design
EUROACTION PLUS is a randomised controlled intervention trial with clinical
follow-up at 16 week.
Vascular patients and people at high risk of developing cardiovascular disease
(CVD) who are current smokers, and their partners, will be identified from
general practice medical notes and will be individually randomised to receive
either a professional nurse coordinated smoking cessation service, which
includes Varenicline, delivered in the context of the 16-week EUROACTION
preventive cardiology programme, or to receive usual care with attention for
all aspects of preventive cardiovascular risk management, however, without
using Varenicline. The results of this smoking cessation service will be
compared against usual care.
Intervention
In the Intervention arm, the cardiovascular screening and risk assessment will
be performed at the
initial and 16-week interview for all patients and their partners. This will
include smoking status, diet,
physical activity, blood pressure, lipids, and diabetes management. Some
psychosocial
measurements including assessment of anxiety and depression and quality of life
will also be
undertaken. All participants will be offered comprehensive, family based,
preventive cardiology
programme, including intensive smoking cessation intervention with Varenicline
(for all patients and
partners who are smokers).
Study burden and risks
As the object of the trial is to reduce the risk of heart attacks and stroke,
the participants can only benefit from their lyfestyle and onterh
cardiovascular risk assessment. Varenicline is a licenced drug and any
potential side effects will be monitored.
By excluding patients with psychiatric problems we will reduce the risk of such
adverse effects as good as possible.
The burden related to this trial is the time-investment of the participating
patients and the risk of a heamatoma by venapuncture.
Exhibition Road
London SW7 2AZ
GB
Exhibition Road
London SW7 2AZ
GB
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 71715857 |
| EudraCT | EUCTR2009-012451-18-NL |
| CCMO | NL30487.041.10 |