Clinical Trial

Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression

Study acronym: SWITCH
Recruiting
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Record status
This record was last updated December 19, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Objective: To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unable(unwilling) to quit smoking. Rationale: Despite the efforts to curb smoking and full awareness of its deleterious health impact, smoking remains a significant contributor to morbidity and mortality. Some health impact of smoking may be improved by other forms of cigarettes than traditional combustion, especially for subjects unwilling or unable to stop smoking. As recently as 2020, one of heated tobacco products (HTP)(IQOS) was FDA Authorized as a 'Reduced Exposure' product. The available evidence to date allows to conclude that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduced body's exposure to harmful or potentially harmful chemicals. There is also evidence indicating lower levels of inflammatory markers and improved vascular function associated with use of heated tobacco products. However, it is unknown whether the reduction in the exposure translates into potential reduction of harm within cardiovascular system, as compared to the traditional (combustion) cigarettes. The evidence is of crucial importance for patients with cardiovascular diseases, medical community, and national health authorities planning evidence based policies regarding HTP/cigarettes.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-12-14; most recent amendment 2024-12-16.
Status change: Not Yet Recruiting → Recruiting 2024-12-16
Trial Details
NCT Number NCT05660798
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Collaborators: PMPSA
Conditions Coronary Artery Disease, Coronary Atherosclerosis, Nicotine Dependence
Enrollment 180 participants
Start Date 2023-02-09
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-19