Smoking Cessation in Patients After Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784702
• Other study ID #: 16/PB/2014
• Status: Completed
• Start date: August 5, 2014
• Est. completion date: January 30, 2017

Study information

• Verified date: March 2021
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 30, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking cessation	Factors influencing smoking cessation. Smoking cessation assessed with NicAlert test and self-reported	30-days, 6-months, 12-months
Other	Cytisine as smoking cessation aid	Feasibility,safety and effectiveness of cytisine. Number of patients with confirmed smoking cessation.Number of adverse events	30-days
Primary	Platelet aggregation in patient treated with clopidogrel after smoking cessation	Platelet reactivity measured with PRU	30-days
Secondary	Prothrombotic state	Various biomarkers	30-days
Secondary	Cotinine	Changes in concentration of cotinine	30-days
Secondary	Thrombin potential	Assessment of endogenous thrombin potential	30-day
Secondary	Thrombomodulin	Changes of thrombomodulin concentration	30-days
Secondary	PAI-1	Changes of PAI-1 concentration	30-days
Secondary	P-selectin	Changes of p-selectin concentration	30-days
Secondary	PF-4	Changes of PF-4 concentration	30-days
Secondary	Thromboglobulin	Changes of thromboglobulin concentration	30-days