NCT04784702

Brief Summary

OBJECTIVES The goal of this study is to evaluate the self-achieved smoking cessation supported with cytisine smoking cessation and its' on platelet aggregation and prothrombotic state in patients after coronary angiography and PCI. BACKGROUND Cigarette smoking is a major risk factor of coronary artery disease (CAD). Smoking cessation is one of the most cost-effective intervention in lifestyle. Self-reported rates of smoking cessation are reasonably low. Cytisine is promising drug in support of smoking cessation. Smoking affects various components leading to arterial thrombosis, and the effect of smoking cessation on prothrombotic state and platelet aggregation is still under investigation GOAL To assess rates of smoking cessation in patients after coronary angiography and PCI and factors influencing success in smoking cessation To assess feasibility, safety and efficacy of cytisine in smoking patients To assess effect of smoking cessation on platelet aggregation in patients treated with clopidogrel and on prothrombotic state. METHODS A prospective nonrandomized observational study of patients after coronary angiography.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

August 5, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

February 25, 2021

Last Update Submit

March 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Platelet aggregation in patient treated with clopidogrel after smoking cessation

    Platelet reactivity measured with PRU

    30-days

Secondary Outcomes (8)

  • Prothrombotic state

    30-days

  • Cotinine

    30-days

  • Thrombin potential

    30-day

  • Thrombomodulin

    30-days

  • PAI-1

    30-days

  • +3 more secondary outcomes

Other Outcomes (2)

  • Smoking cessation

    30-days, 6-months, 12-months

  • Cytisine as smoking cessation aid

    30-days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable CAD and ACS admitted to the catheterization laboratory in the Department of Cardiology, Grochowski Hospital, Warsaw, Poland

You may qualify if:

  • Patients after coronary angiography or PCI,
  • Aged 18 years or older,
  • Smoking at least 10 cigarettes a day

You may not qualify if:

  • Pregnancy
  • Criteria may vary in substudies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Adjunct, Director of the Programme

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 5, 2021

Study Start

August 5, 2014

Primary Completion

December 31, 2016

Study Completion

January 30, 2017

Last Updated

March 5, 2021

Record last verified: 2021-03