- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566678
Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease
May 22, 2023 updated by: Philip Morris Products S.A.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christelle Haziza, PhD
- Phone Number: +41582421111
- Email: Christelle.Haziza@pmi.com
Study Contact Backup
- Name: Sandrine Pouly, PhD
- Phone Number: +41582421111
- Email: Sandrine.Pouly@pmi.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Main Inclusion Criteria:
- History of coronary artery disease, defined as documented CAD (stable) with coronary artery stenosis on coronary angiogram ≥50% (incl. Percutaneous Coronary Intervention (PCI) / Coronary artery bypass graft surgery (CABG)) in the medical history or previously documented acute coronary syndrome (ACS) / myocardial infarction occurring more than 1 month prior to V1. AND / OR, History of peripheral artery disease (PAD) defined as ABI <0.9 or TBI <0.6 or clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Fontaine's stages I, IIa and IIb.
- Body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or 40 kg (female).
- Subject has a smoking history of at least 10 years.
- Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
- Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
- For subjects not willing to quit smoking only: have been advised to quit smoking and informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
- Subjects willing to quit smoking only: willing to and set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions
Main Exclusion Criteria:
- Planned peripheral or coronary intervention or surgical procedure.
- Unstable angina pectoris.
- Critical limb ischemia (absolute peripheral pressures <50mmHg).
- Recent (< 30 days) PAD revascularization therapy prior to V1.
- Recent ACS / myocardial infarction or stroke / TIA <30 days prior to V1.
- Pre-existing symptomatic heart failure with reduced ejection fraction (EF<35%).
- Planned peripheral or coronary intervention or surgical procedure related to CAD or PAD.
- Subjects with spirometry values indicating chronic obstructive pulmonary disease (COPD) GOLD* Stage 3 or 4 (FEV1/FVC <0.7 & FEV1 <50% predicted [post-BD])
- Existing known serious infection or chronic inflammatory systemic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, uncontrolled diabetes (HbA1c ≥ 7.0 % [or ≥ 53.0 mmol/mol]) or uncontrolled hypertension (systolic blood pressure≥140 mmHg and / or diastolic blood pressure ≥90 mmHg., stage 4 and 5 chronic kidney disease, etc…).
- Currently active cancer or history of cancer within the last 5 years prior to V1.
- History of alcohol and / or drug abuse (other than tetrahydrocannabinol [THC]).
- Positive serology test (human immunodeficiency virus (HIV) 1/2), hepatitis B and / or C).
- Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
- Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
- For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.
[*Global Initiative for Obstructive Lung Disease]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cigarette
Smokers who self-selected to continue smoking cigarettes.
|
Subjects who self-selected to continue smoking their own preferred brand of commercially available cigarettes.
|
Active Comparator: Tobacco Heating System
Smokers who self-selected to switch to THS use.
|
Subjects who self-selected to quit smoking during the study duration will switch from cigarettes to using THS.
Other Names:
|
Active Comparator: Smoking Abstinence
Smokers who self-selected to abstain from smoking.
|
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.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow mediated dilation
Time Frame: From baseline to 12 months.
|
Change from baseline in flow mediated dilation (%FMD) of the brachial artery at 12 months before administration of a vasodilator (nitroglycerin)
|
From baseline to 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Christelle Haziza, PhD, Philip Morris Products S.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 15, 2023
Primary Completion (Anticipated)
March 31, 2023
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P1-CVD-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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