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Completed

NCT Number: NCT04784702

Smoking Cessation in Patients After Coronary Angiography

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Criteria may vary in substudies

Treatment and study plan

Primary outcomes

  1. Platelet aggregation in patient treated with clopidogrel after smoking cessation

    Time frame: 30-days

    Platelet reactivity measured with PRU

Secondary outcomes

  1. Prothrombotic state

    Time frame: 30-days

    Various biomarkers

  2. Cotinine

    Time frame: 30-days

    Changes in concentration of cotinine

  3. Thrombin potential

    Time frame: 30-day

    Assessment of endogenous thrombin potential

  4. Thrombomodulin

    Time frame: 30-days

    Changes of thrombomodulin concentration

  5. PAI-1

    Time frame: 30-days

    Changes of PAI-1 concentration

  6. P-selectin

    Time frame: 30-days

    Changes of p-selectin concentration

  7. PF-4

    Time frame: 30-days

    Changes of PF-4 concentration

  8. Thromboglobulin

    Time frame: 30-days

    Changes of thromboglobulin concentration

Other outcomes

  1. Smoking cessation

    Time frame: 30-days, 6-months, 12-months

    Factors influencing smoking cessation. Smoking cessation assessed with NicAlert test and self-reported

  2. Cytisine as smoking cessation aid

    Time frame: 30-days

    Feasibility,safety and effectiveness of cytisine. Number of patients with confirmed smoking cessation.Number of adverse events

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

Smoking Cessation in Patients After Coronary Angiography - Self-achieved and Supported With Cytisine and Its' Effect on Platelet Aggregation

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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