Real-World Evidence Retrospective Cardiovascular Outcome Study among Users of Heated Tobacco Products (HTPs) Compared to Smokers of Cigarettes (CIG), Former Smokers, and Never Smokers in Japan

Real-World Evidence Retrospective Cardiovascular Outcome Study among Users of Heated Tobacco Products (HTPs) Compared to Smokers of Cigarettes (CIG), Former Smokers, and Never Smokers in Japan - RWE Retrospective Cardiovascular Outcome Study in Users of HTPs in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057799

Enrollment

5490

Registered

2025-05-09

Start date

2024-12-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-fatal myocardial infarction, unstable angina

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with any healthcare encounter records in the Tokushukai Medical Database -Patients with first record of Index Event (first-ever [defined as first identified or first recorded in the Tokushukai Medical Database] of any of the following: non-fatal MI, unstable angina, or urgent coronary revascularization procedure) from 1st May 2016 to 31st December 2020 -Age 30 years or older at the time of the Index Event -Patients of any gender -Patients or relatives who are able to understand the information provided in the ICF and have signed it

Exclusion criteria

Exclusion criteria: -Employees of Tobacco industries or their families such as their parents -Employees of Philip Morris International (PMI) and its affiliate companies, Tokushukai Medical Corporation, 3H Medi Solution, or Syneos Health Clinical K.K.

Design outcomes

Primary

Measure	Time frame
To compare the time from Index Event to a first subsequent MACE between comparable groups of exclusive HTP users and exclusive CIG smokers. -Index Event will be defined as first-ever (defined as first identified or first recorded in the Tokushukai Medical Database) of any of the following: non-fatal MI, unstable angina, or urgent coronary revascularization procedure. -MACE (called hereafter as Broad Modified MACE, defined as a 6-point composite endpoint of any of the following): ->Non-fatal MI, ->Non-fatal stroke, ->Hospitalization for angina, ->Hospitalization for heart failure, ->Urgent revascularization for angina, or ->All-cause mortality	—

Measure

Time frame

To compare the time from Index Event to a first subsequent MACE between comparable groups of exclusive HTP users and exclusive CIG smokers. -Index Event will be defined as first-ever (defined as first identified or first recorded in the Tokushukai Medical Database) of any of the following: non-fatal MI, unstable angina, or urgent coronary revascularization procedure. -MACE (called hereafter as Broad Modified MACE, defined as a 6-point composite endpoint of any of the following): ->Non-fatal MI, ->Non-fatal stroke, ->Hospitalization for angina, ->Hospitalization for heart failure, ->Urgent revascularization for angina, or ->All-cause mortality

—

Secondary

Measure	Time frame
1.To compare the time from Index Event to all-cause mortality between comparable groups of (i) exclusive HTP users versus exclusive CIG smokers, (ii) exclusive HTP users versus dual users of CIG and HTP, (iii) exclusive HTP users versus former smokers, and (iv) exclusive HTP users versus never smokers. Endpoint: -All-cause morality 2.To compare the time from Index Event to a first subsequent Broad Modified MACE defined above between comparable groups of (i) exclusive HTP users versus former smokers, (ii) exclusive HTP users versus dual users of CIG and HTP, and (iii) exclusive HTP users versus and never smokers. 3. To compare the number and frequency of first subsequent CVD-related hospitalizations (defined as hospitalizations due to MI, unstable angina, or stroke) by comparable tobacco exposure groups (never smokers, former smokers, dual users of CIG and HTP, exclusive CIG smokers, and exclusive HTP users). Endpoint: -Annual numbers and frequency of first subsequent hospitalizations due to MI, unstable angina, or stroke as a composite endpoint. 4. To evaluate whether the time from Index Event to a first subsequent MACE for exclusive HTP users vs. exclusive CIG smokers as defined above varies for exclusive HTP users by: -The number of years of HTP use (<1 year, 1-3 years, >3 years). -Age at Index Event -Sex -History of other CVD prior to the Index Event (e.g., stroke, hypertension, peripheral vascular disease [PVD])	—

Measure

Time frame

1.To compare the time from Index Event to all-cause mortality between comparable groups of (i) exclusive HTP users versus exclusive CIG smokers, (ii) exclusive HTP users versus dual users of CIG and HTP, (iii) exclusive HTP users versus former smokers, and (iv) exclusive HTP users versus never smokers. Endpoint: -All-cause morality 2.To compare the time from Index Event to a first subsequent Broad Modified MACE defined above between comparable groups of (i) exclusive HTP users versus former smokers, (ii) exclusive HTP users versus dual users of CIG and HTP, and (iii) exclusive HTP users versus and never smokers. 3. To compare the number and frequency of first subsequent CVD-related hospitalizations (defined as hospitalizations due to MI, unstable angina, or stroke) by comparable tobacco exposure groups (never smokers, former smokers, dual users of CIG and HTP, exclusive CIG smokers, and exclusive HTP users). Endpoint: -Annual numbers and frequency of first subsequent hospitalizations due to MI, unstable angina, or stroke as a composite endpoint. 4. To evaluate whether the time from Index Event to a first subsequent MACE for exclusive HTP users vs. exclusive CIG smokers as defined above varies for exclusive HTP users by: -The number of years of HTP use (<1 year, 1-3 years, >3 years). -Age at Index Event -Sex -History of other CVD prior to the Index Event (e.g., stroke, hypertension, peripheral vascular disease [PVD])

—

Countries

Japan

Contacts

Public ContactTakashi Sato

Syneos Health Clinical K.K. Clinical Operations/Real World and Late Phase

takashi.sato@syneoshealth.com03-6733-9690

Outcome results