Clinical Trial Results:
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
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Summary
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EudraCT number |
2009-012451-18 |
Trial protocol |
GB ES NL |
Global end of trial date |
31 Jul 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jan 2020
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First version publication date |
02 Jan 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CRO1202
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Additional study identifiers
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ISRCTN number |
ISRCTN22073647 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Professor David Wood, Imperial College London, +44 (0)20 8846 7352, d.wood@imperial.ac.uk
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Scientific contact |
Professor David Wood, Imperial College London, +44 (0)20 8846 7352, d.wood@imperial.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jan 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Dec 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 105
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Country: Number of subjects enrolled |
Spain: 173
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Country: Number of subjects enrolled |
United Kingdom: 232
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Country: Number of subjects enrolled |
Italy: 186
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Worldwide total number of subjects |
696
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EEA total number of subjects |
696
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
341
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From 65 to 84 years |
355
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85 years and over |
0
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Recruitment
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Recruitment details |
A multi-center parallel-group randomized controlled trial (RCT) was conducted in 20 General Practice across Italy, Spain, the Netherlands, and the UK. Patients were randomized individually within practices to participate in the EUROACTION intervention program. | |||||||||||||||
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Pre-assignment
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Screening details |
The trial started in October 2009 and was completed in July 2011. Persistent smokers (men and women) with vascular disease or at high cardiovascular risk were identified from the practice register | |||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Euroaction Plus (EU+) | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Champix
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Investigational medicinal product code |
Varenicline Tartrate
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Varinecline will be introduced within the first 4 weeks after baseline assessment and will be initiated 1 week before the patient's chosen quit date. The dose of varenicline will be titrated as follows: 0.5 mg for days 1 to 3, 0.5 mg twice per day on days 4 to 7, then 1 mg twice per day through week 12. The target quit date will be within 4 weeks of starting varenicline.
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Arm title
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Usual Care (UC) | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
usual care products | |||||||||||||||
Investigational medicinal product name |
Usual care
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Investigational medicinal product code |
Varenicline Tartrate
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
16 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Euroaction Plus (EU+)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Usual Care (UC)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Euroaction Plus (EU+)
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Reporting group description |
- | ||
Reporting group title |
Usual Care (UC)
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Reporting group description |
- | ||
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End point title |
Percent of the participants who quit smoking | |||||||||
End point description |
Self-reported abstinence from smoking - 7-day point (period) prevalence of non-smoking
Bedfont Micro + Smokerlyzer Breath carbon monoxide (CO), 10 parts per million
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End point type |
Primary
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End point timeframe |
16 weeks
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Statistical analysis title |
Quit smoking | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
683
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.01 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Percent of the participants who eat Fruit and vegetables ≥400 g/day | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
Fruit and vegetables ≥400 g/day | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
546
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.27 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Percent of participants who eat Fish ≥20 g/day or oily fish ≥3 x/week | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
Fish ≥20 g/day or oily fish ≥3 x/week | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
546
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.02 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Percent of participants who consume Alcohol ≤30 g/day | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
Alcohol ≤30 g/day | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
534
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.04 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Participnats with Mediterranean diet score ≥9 | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
Mediterranean diet score ≥9 | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
545
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
< 0.001 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
≥30 min physical activity moderate intensity at least 5 x/week | |||||||||
End point description |
≥30 min physical activity moderate intensity at least 5 x/week Or ≥3 × 20 min vigorous activity/week
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
≥30 min physical activity moderate intensity | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
547
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.002 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Percent of participants with Ideal BMI (25 kg/m2) | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
Ideal BMI (25 kg/m2) | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
575
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.02 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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End point title |
Percent of participants with SBP/DBP ,130/80 mmHg | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
16 weeks
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Statistical analysis title |
SBP/DBP ,130/80 mmHg | |||||||||
Comparison groups |
Euroaction Plus (EU+) v Usual Care (UC)
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Number of subjects included in analysis |
581
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Analysis specification |
Post-hoc
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Analysis type |
superiority | |||||||||
P-value |
= 0.02 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
16 weeks
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Assessment type |
Non-systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Euroaction Plus (EU+)
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Usual Care (UC)
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Reporting group description |
- | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse event was reported. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The investigators were only able to evaluate the outcomes at the end of our 16 weeks nurse-led programme and whether abstinence from tobacco, a healthier lifestyle and risk factor control achieved are sustained to 1 year remains an open question. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/24616337 |
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