Coronary Artery DiseaseNCT04784702
Smoking Cessation in Patients After Coronary Angiography
An observational study of Coronary Artery Disease, run by Centre of Postgraduate Medical Education.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2014to 30 Jan 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable CAD and ACS admitted to the catheterization laboratory in the Department of Cardiology, Grochowski Hospital, Warsaw, Poland
Who may be able to join
- Patients after coronary angiography or PCI,
- Aged 18 years or older,
- Smoking at least 10 cigarettes a day
Who cannot join
- Pregnancy
- Criteria may vary in substudies
About this study
Official title: Smoking Cessation in Patients After Coronary Angiography - Self-achieved and Supported With Cytisine and Its' Effect on Platelet Aggregation
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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation in patient treated with clopidogrel after smoking cessation
Platelet reactivity measured with PRU
Measured: 30-days
Secondary outcomes (8)
Prothrombotic state
Various biomarkers
Measured: 30-days
Cotinine
Changes in concentration of cotinine
Measured: 30-days
Thrombin potential
Assessment of endogenous thrombin potential
Measured: 30-day
Thrombomodulin
Changes of thrombomodulin concentration
Measured: 30-days
PAI-1
Changes of PAI-1 concentration
Measured: 30-days
P-selectin
Changes of p-selectin concentration
Measured: 30-days
PF-4
Changes of PF-4 concentration
Measured: 30-days
Thromboglobulin
Changes of thromboglobulin concentration
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start5 Aug 2014
- Primary completion31 Dec 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bogumil Ramotowski, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784702
- Sponsor's protocol ID
- 16/PB/2014
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Patients After Coronary Angiography - Self-achieved and Supported With Cytisine and Its' Effect on Platelet Aggregation
- ClinicalTrials.gov ID
- NCT04784702
- Acronym / sponsor ID
- 16/PB/2014
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 5 Mar 2021 (actual)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable CAD and ACS admitted to the catheterization laboratory in the Department of Cardiology, Grochowski Hospital, Warsaw, Poland
Key inclusion criteria (3 listed)
- Patients after coronary angiography or PCI,
- Aged 18 years or older,
- Smoking at least 10 cigarettes a day
Key exclusion criteria (2 listed)
- Pregnancy
- Criteria may vary in substudies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet aggregation in patient treated with clopidogrel after smoking cessation
Time frame: 30-days
Platelet reactivity measured with PRU
8 secondary outcomes
Prothrombotic state
Time frame: 30-days
Cotinine
Time frame: 30-days
Thrombin potential
Time frame: 30-day
Thrombomodulin
Time frame: 30-days
PAI-1
Time frame: 30-days
P-selectin
Time frame: 30-days
PF-4
Time frame: 30-days
Thromboglobulin
Time frame: 30-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Centre of Postgraduate Medical Education.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet aggregation in patient treated with clopidogrel after smoking cessation (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2021.