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

Coronary Artery Disease Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05566678
• Study type: Interventional
• Source: Philip Morris Products S.A.
• Status: Withdrawn
• Phase: N/A
• Start date: March 15, 2023
• Completion date: March 31, 2023