NCT02307045

Brief 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. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

6 years

First QC Date

December 1, 2014

Last Update Submit

April 1, 2020

Conditions

Smoking Cessation

Keywords

Arterial stiffnessEndothelial Glycocalyx

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Baseline, 1 month, 3 months, 6 months and 12 months.

  • Follow up for cardiovascular events

    baseline , ten years

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po

Drug: Varenicline

nicotine

ACTIVE COMPARATOR

Nicotine replacement therapy with transdermal patches and/or chewing gums

Drug: nicotine

Interventions

VareniclineDRUG

Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po

Also known as: Champix (varenicline)
varenicline
nicotineDRUG

Nicotine replacement therapy with transdermal patches and/or chewing gums

Also known as: Nicorette (nicotine)
nicotine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers

You may not qualify if:

  • Coronary artery disease
  • Heart failure
  • Diabetes mellitus
  • Dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (1)

  • 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.

    PMID: 28549278DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

VareniclineNicotineNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesSolanaceous AlkaloidsAlkaloidsPyridinesHeterocyclic Compounds, 1-RingChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ignatios Ikonomidis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Kalliroi Kourea, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • George Pavlidis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Margarita Marinou, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • John Lekakis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Cardiology

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

December 3, 2014

Primary Completion

November 30, 2020

Study Completion

December 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

GR(1)