NCT05566678

Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease

A 12-month, 3-group, Preference, Multi-center Study to Demonstrate the Effects of Switching From Cigarettes to Tobacco Heating System (THS) on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate improvement in flow mediated dilation (FMD), a functional endpoint associated with the progression of atherosclerosis, when switching from cigarettes to the Tobacco Heating System (THS) in subjects with peripheral arterial disease (PAD) and/or coronary artery disease (CAD). The study is planned to be conducted in the US, Europe, and Asia.

Detailed description

The goal of this longitudinal study is to demonstrate improvement in FMD, a functional endpoint associated with the progression of atherosclerosis and a predictor of future cardiovascular (CV) events in subjects with PAD and/or CAD, when switching from cigarettes to THS. Other CV functional endpoints, or cardiovascular biomarkers of potential harm (BoPH) representative of different pathophysiologic pathways associated with increased CV risk in smokers with established atherosclerosis will be assessed. It is expected that the totality of the evidence from this study will show the potential of THS to slow down the progression of atherosclerosis, thus helping to delay a CV event, or delaying a secondary event.

Conditions

• Cardiovascular Diseases
• Smoking
• Tobacco Use
• Peripheral Arterial Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Cigarette	Subjects who self-selected to continue smoking their own preferred brand of commercially available cigarettes.
OTHER	THS	Subjects who self-selected to quit smoking during the study duration will switch from cigarettes to using THS.
OTHER	Smoking Abstinence	Subjects who self-selected to quit smoking may be prescribed Nicotine Replacement Therapy (NRT) to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-10-04
• Last updated: 2024-11-18