Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04784702
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smoking Cessation in Patients After Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': '30-days, 6-months, 12-months', 'description': 'Factors influencing smoking cessation. Smoking cessation assessed with NicAlert test and self-reported'}, {'measure': 'Cytisine as smoking cessation aid', 'timeFrame': '30-days', 'description': 'Feasibility,safety and effectiveness of cytisine. Number of patients with confirmed smoking cessation.Number of adverse events'}], 'primaryOutcomes': [{'measure': 'Platelet aggregation in patient treated with clopidogrel after smoking cessation', 'timeFrame': '30-days', 'description': 'Platelet reactivity measured with PRU'}], 'secondaryOutcomes': [{'measure': 'Prothrombotic state', 'timeFrame': '30-days', 'description': 'Various biomarkers'}, {'measure': 'Cotinine', 'timeFrame': '30-days', 'description': 'Changes in concentration of cotinine'}, {'measure': 'Thrombin potential', 'timeFrame': '30-day', 'description': 'Assessment of endogenous thrombin potential'}, {'measure': 'Thrombomodulin', 'timeFrame': '30-days', 'description': 'Changes of thrombomodulin concentration'}, {'measure': 'PAI-1', 'timeFrame': '30-days', 'description': 'Changes of PAI-1 concentration'}, {'measure': 'P-selectin', 'timeFrame': '30-days', 'description': 'Changes of p-selectin concentration'}, {'measure': 'PF-4', 'timeFrame': '30-days', 'description': 'Changes of PF-4 concentration'}, {'measure': 'Thromboglobulin', 'timeFrame': '30-days', 'description': 'Changes of thromboglobulin concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nBACKGROUND 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.\n\nMETHODS A prospective nonrandomized observational study of patients after coronary angiography."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable CAD and ACS admitted to the catheterization laboratory in the Department of Cardiology, Grochowski Hospital, Warsaw, Poland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after coronary angiography or PCI,\n* Aged 18 years or older,\n* Smoking at least 10 cigarettes a day\n\nExclusion Criteria:\n\n• Pregnancy\n\nCriteria may vary in substudies'}, 'identificationModule': {'nctId': 'NCT04784702', 'briefTitle': 'Smoking Cessation in Patients After Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Centre of Postgraduate Medical Education'}, 'officialTitle': "Smoking Cessation in Patients After Coronary Angiography - Self-achieved and Supported With Cytisine and Its' Effect on Platelet Aggregation", 'orgStudyIdInfo': {'id': '16/PB/2014'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Adjunct, Director of the Programme', 'investigatorFullName': 'Bogumil Ramotowski', 'investigatorAffiliation': 'Centre of Postgraduate Medical Education'}}}}