Smoking CessationPhase 4NCT02307045
Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function
A Phase 4 study testing Varenicline and nicotine in people with Smoking Cessation, run by University of Athens at 1 site in Greece.
Trial summary
The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline and nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGreece
- Study dates
- 3 Dec 2014to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers
Who cannot join
- Coronary artery disease
- Heart failure
- Diabetes mellitus
- Dyslipidemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs
Read the detailed description
The investigators will examine smokers without cardiovascular disease treated with transdermal nicotine patches and/or varenicline at before, 4, 12, 24 and 48 weeks after treatment during validated smoking cessation program. The investigators will measure changes between baseline and 4,12,24, and 48 weeks after treatment of :
- exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
- carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
- perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glucocalyx thickness because of a for deeper penetration of the RBC in the glucocalyx
- oxidative stress, thrombosis and inflammatory biomarkers in blood samples.
Non smokers of similar age and sex will serve as controls.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, nicotine
- Keywords
- Arterial stiffness, Endothelial Glycocalyx
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix (varenicline)
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
nicotineDrug
Also called Nicorette (nicotine)
Nicotine replacement therapy with transdermal patches and/or chewing gums
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Active comparator | Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po Receives: Drug: Varenicline |
| nicotine | Active comparator | Nicotine replacement therapy with transdermal patches and/or chewing gums Receives: Drug: nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelial function between baseline and during medically-aided smoking cessation program.
Changes in endothelial function between baseline and during medically-aided smoking cessation program as assessed by endothelial glycocalyx thickness.
Measured: Baseline, 1 month, 3 months, 6 months and 12 months.
Secondary outcomes (2)
Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program.
Changes in vascular function between baseline and during medically-aided as assessed by a composite of pulse wave velocity, augmentation index and central aortic blood pressure.
Measured: Baseline, 1 month, 3 months, 6 months and 12 months.
Follow up for cardiovascular events
Association of endothelial glycocalyx as assessed by perfused boundary region (μm) with adverse cardiac events (composite of death, myocardial infarction, stroke , hospitalization for heart failure) during ten year follow -up in smokers and non-smoker subjects
Measured: baseline , ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start3 Dec 2014
- Primary completion30 Nov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceKalliroi Kourea, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceGeorge Pavlidis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceMargarita Marinou, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceJohn Lekakis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307045
- Sponsor's protocol ID
- SMOKING-VAR-NIC-ATTIKON
- Status last verified
- Apr 2020
- First submitted
- 1 Dec 2014
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ikonomidis I, Marinou M, Vlastos D, Kourea K, Andreadou I, Liarakos N, Triantafyllidi H, Pavlidis G, Tsougos E, Parissis J, Lekakis J. Effects of varenicline and nicotine replacement therapy on arterial elasticity, endothelial glycocalyx and oxidative stress during a 3-month smoking cessation program. Atherosclerosis. 2017 Jul;262:123-130. doi: 10.1016/j.atherosclerosis.2017.05.012. Epub 2017 May 13.
PubMed 28549278
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
- ClinicalTrials.gov ID
- NCT02307045
- Acronym / sponsor ID
- SMOKING-VAR-NIC-ATTIKON
- Conditions
- Smoking Cessation
- Keywords
- Arterial stiffness, Endothelial Glycocalyx
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs
Detailed description
The investigators will examine smokers without cardiovascular disease treated with transdermal nicotine patches and/or varenicline at before, 4, 12, 24 and 48 weeks after treatment during validated smoking cessation program. The investigators will measure changes between baseline and 4,12,24, and 48 weeks after treatment of :
- exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
- carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
- perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glucocalyx thickness because of a for deeper penetration of the RBC in the glucocalyx
- oxidative stress, thrombosis and inflammatory biomarkers in blood samples.
Non smokers of similar age and sex will serve as controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Active comparator | Drug: VareniclineStimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po |
| nicotine | Active comparator | Drug: nicotineNicotine replacement therapy with transdermal patches and/or chewing gums |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smokers
Key exclusion criteria (4 listed)
- Coronary artery disease
- Heart failure
- Diabetes mellitus
- Dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: Champix (varenicline)Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po | Drug | varenicline |
| nicotineAlso: Nicorette (nicotine)Nicotine replacement therapy with transdermal patches and/or chewing gums | Drug | nicotine |
Primary outcome
Changes in endothelial function between baseline and during medically-aided smoking cessation program.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.
Changes in endothelial function between baseline and during medically-aided smoking cessation program as assessed by endothelial glycocalyx thickness.
2 secondary outcomes
Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.
Follow up for cardiovascular events
Time frame: baseline , ten years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 28549278Ikonomidis I, Marinou M, Vlastos D, Kourea K, Andreadou I, Liarakos N, Triantafyllidi H, Pavlidis G, Tsougos E, Parissis J, Lekakis J. Effects of varenicline and nicotine replacement therapy on arterial elasticity, endothelial glycocalyx and oxidative stress during a 3-month smoking cessation program. Atherosclerosis. 2017 Jul;262:123-130. doi: 10.1016/j.atherosclerosis.2017.05.012. Epub 2017 May 13.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignatios Ikonomidis, MD principal investigator
2nd Cardiology Department, University of Athens, Greece
Kalliroi Kourea, MD principal investigator
2nd Cardiology Department, University of Athens, Greece
George Pavlidis, MD principal investigator
2nd Cardiology Department, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline and nicotine in people with Smoking Cessation, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in endothelial function between baseline and during medically-aided smoking cessation program. (time frame: Baseline, 1 month, 3 months, 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.