Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03837704
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2019-01-21
Brief Title:
Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS Continue Smoking or Quit Smoking
Sponsor:
Philip Morris Products SA
Organization:
Philip Morris Products SA
Study Overview
Official Title:
A Controlled Open-label 3-arm Parallel Group Multi-center Study to Evaluate the Abdominal Aortic Aneurysm AAA Growth Rate in Adult Smoking Patients Randomized to Either Cigarette Smoking or IQOS Use and to Compare With the AAA Growth Rate in Patients Who Had Stopped Smoking
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 evaluate the reduction of the Abdominal Aortic Aneurysm AAA annual growth rate in patients who switch from smoking cigarettes to using IQOS as compared to patients who continue to smoke cigarettes The study also aims to provide context to the scale of reduction in the growth rate by comparing the AAA annual growth rates for continuing to smoke and switching to IQOS with the AAA annual growth rate in smokers who had stopped smoking The study will further evaluate the effects of switching to IQOS on co-morbidities observed in AAA patients that are related to smoking as well as to assess the effects on relevant clinical risk endpoints linked to smoking related diseases
Detailed Description:
This is a controlled open-label 3-arm parallel group multi-center study in patients diagnosed with Abdominal Aortic Aneurysm AAA to evaluate the AAA annual growth rate in adult smokers randomized to either continue smoking combustible cigarettes CC or to switch to IQOS and in adults who had stopped smoking as a non-randomized control arm
This is a descriptive study designed to gain an understanding of how changes in smoking behaviors impact AAA growth rate and disease progression Therefore there are no formal statistical hypotheses to be tested
Smoking patients with AAA who did not quit smoking after their AAA diagnosis and who are not intending to quit within the next 6 months will be screened for enrollment and randomization in the CC and IQOS arms if all other eligibility criteria are met
Smoking patients with AAA who had completely stopped smoking and using of any other tobacco or nicotine-containing products within 2 months of their AAA diagnosis and are still abstinent at the time of the Screening Visit and of the Baseline Visit will be screened to be enrolled in the smoking cessation SC arm without randomization
This is a descriptive study designed to gain an understanding of how changes in smoking behaviors impact AAA growth rate and disease progression Therefore there are no formal statistical hypotheses to be tested
Smoking patients with AAA who did not quit smoking after their AAA diagnosis and who are not intending to quit within the next 6 months will be screened for enrollment and randomization in the CC and IQOS arms if all other eligibility criteria are met
Smoking patients with AAA who had completely stopped smoking and using of any other tobacco or nicotine-containing products within 2 months of their AAA diagnosis and are still abstinent at the time of the Screening Visit and of the Baseline Visit will be screened to be enrolled in the smoking cessation SC arm without randomization
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