Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05566678
Status:
WITHDRAWN
Last Update Posted:
2023-05-24
First Post:
2022-09-30
Brief Title:
Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease
Sponsor:
Philip Morris Products SA
Organization:
Philip Morris Products SA
Study Overview
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WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped before enrollment after a feasibility review revealed we would be unable to measure the primary endpoint flow mediated dilation - FMD with a high degree of reproducibility and minimum variability in a multi-country setting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None