Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression

Last updated: December 16, 2024
Sponsor: National Institute of Cardiology, Warsaw, Poland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Vascular Diseases

Stimulant Use Disorder

Treatment

heated tobacco - lifestyle intervention

Clinical Study ID

NCT05660798
SWITCH01
  • Ages 18-75
  • All Genders

Study Summary

Objective:

To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unable(unwilling) to quit smoking.

Rationale:

Despite the efforts to curb smoking and full awareness of its deleterious health impact, smoking remains a significant contributor to morbidity and mortality. Some health impact of smoking may be improved by other forms of cigarettes than traditional combustion, especially for subjects unwilling or unable to stop smoking. As recently as 2020, one of heated tobacco products (HTP)(IQOS) was FDA Authorized as a 'Reduced Exposure' product. The available evidence to date allows to conclude that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduced body's exposure to harmful or potentially harmful chemicals. There is also evidence indicating lower levels of inflammatory markers and improved vascular function associated with use of heated tobacco products. However, it is unknown whether the reduction in the exposure translates into potential reduction of harm within cardiovascular system, as compared to the traditional (combustion) cigarettes.

The evidence is of crucial importance for patients with cardiovascular diseases, medical community, and national health authorities planning evidence based policies regarding HTP/cigarettes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults aged >18 years and <75 years

  2. Subjects with stable chronic coronary syndrome defined as the presence of at leastone coronary artery stenosis >=20% due to coronary plaque visible on coronarycomputed tomography angiography (CCTA), in an artery with a reference diameter > 2.0mm

  3. History of smoking pack-years ≥10 (Pack-years will be calculated by taking theaverage number of cigarettes smoked per day divided by 20 and multiplied by thenumber of years smoked), based on self-reporting

  4. Current smokers with a minimum of self-reported current smoking pattern of >10cigarettes/day during the last 6 months prior to screening, smoking status will beverified based on a urinary cotinine test (cotinine ≥200 ng/mL)

  5. Patients that have been advised to quit smoking and informed of a smoking risk andcessation programs (per local SOC) and who are still not willing to set a quit datewithin the next 30 days at screening

  6. Stable treatment for coronary atherosclerosis according to the guidelines

  7. Have understood the study and have signed informed consent

Exclusion

Exclusion Criteria:

  1. Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstableangina or revascularization within 30 days prior to screening

  2. Planned coronary intervention (PCI, CABG) at screening

  3. Previous CABG

  4. Preexisting heart failure with reduced ejection fraction (EF <50%)

  5. Severe uncontrolled hypertension (at the discretion of investigator)

  6. Diabetes

  7. Subjects with documented genetic familial hypercholesterolemia

  8. Subjects have known serious infection or chronic inflammatory systemic disease (e.g.rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)

  9. Subjects have a known non-cardiovascular disease that is associated with poorprognosis (e.g. metastatic cancer)

  10. Patient with currently active cancer or history of cancer within the last 5 years

  11. Subjects have hypersensitivity or any other warnings listed in the local labelingfor THS

  12. Subjects have hypersensitivity to imaging iodine contrast agents

  13. GFR<45 ml/min/1,73 m2

  14. Subjects who could not participate for any reason other than medical (e.g.,psychological and/or social reason) per Investigator's judgment

  15. Subjects have any other clinical condition that would jeopardize the subject'ssafety while participating in this study, per Investigator's judgment

  16. Female subject is pregnant or breast-feeding, or planning to become pregnant duringthe study

  17. Subjects have previously participated in this study, or in an interventional study (drug or medical device) within 30 days of screening (participation in observationalstudies/registries allowed)

  18. Subjects have a close affiliation with the investigational site: a close relative ofthe investigator, a person dependent on the investigational site (e.g. employee orstudent of the investigational site)

  19. Subjects are current or former employee of the tobacco industry or theirfirst-degree relatives (parent, child, spouse)

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: heated tobacco - lifestyle intervention
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Objective:

To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unable(unwilling) to quit smoking.

Background Despite the efforts to curb smoking and full awareness of its deleterious health impact, smoking remains a significant contributor to morbidity and mortality. Some health impact of smoking may be improved by other forms of cigarettes than traditional combustion, especially for subjects unwilling or unable to stop smoking. As recently as 2020, one of heated tobacco products (HTP)(IQOS) was FDA Authorized as a 'Reduced Exposure' product. The available evidence to date allows to conclude that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduced body's exposure to harmful or potentially harmful chemicals. There is also evidence indicating lower levels of inflammatory markers and improved vascular function associated with use of heated tobacco products. However, it is unknown whether the reduction in the exposure translates into potential reduction of harm within cardiovascular system, as compared to the traditional (combustion) cigarettes.

The evidence is of crucial importance for patients with cardiovascular diseases, medical community, and national health authorities planning evidence based policies regarding HTP/cigarettes.

Methods:

Prospective, single-centre, open-label, randomised study including 180 stable patients with coronary artery disease (CAD) as diagnosed on CCTA, without indications for invasive treatment, unable(unwilling) to quit smoking, randomised 1:1 to either heated (group H) or combustion (group C) tobacco products and followed for 18 months. The follow-up is accomplished with CCTA scan. The study clinical visits are planned at 1, 3, 6, 12, and 18 months.

The primary outcome is change in non calcified plaque volume at 18 months between H and C groups (intention to treat design).

Connect with a study center

  • National Institute of Cardiology

    Warsaw, 04-628
    Poland

    Active - Recruiting

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