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

NCT05566678 | Withdrawn

• 1 other identifier: P1-CVD-05
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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) and/or coronary artery disease (CAD). The study is planned to be conducted in the US, Europe, and Asia.

Conditions

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

Keywords

Flow Mediated Dilation; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilation

  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.

Study Arms (3)

Cigarette

ACTIVE COMPARATOR

Smokers who self-selected to continue smoking cigarettes.

Other: Cigarette

Tobacco Heating System

ACTIVE COMPARATOR

Smokers who self-selected to switch to THS use.

Other: THS

Smoking Abstinence

ACTIVE COMPARATOR

Smokers who self-selected to abstain from smoking.

Other: Smoking Abstinence

Interventions

Cigarette OTHER

Subjects who self-selected to continue smoking their own preferred brand of commercially available cigarettes.

Cigarette

THS OTHER

Subjects who self-selected to quit smoking during the study duration will switch from cigarettes to using THS.

Also known as: Tobacco Heating System 3.0

Tobacco Heating System

Smoking Abstinence OTHER

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.)

Smoking Abstinence

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Smoking; Tobacco Use; Peripheral Arterial Disease; Coronary Artery Disease; Atherosclerosis

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A three-group ambulatory preference design, multi-center study

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: March 15, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share