UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057799 |
|---|---|
| Receipt number | R000065853 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/05/09 |
| Last modified on | 2025/05/08 13:47:18 |
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Basic information
Public title
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
Acronym
RWE Retrospective Cardiovascular Outcome Study in Users of HTPs in Japan
Scientific Title
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
Scientific Title:Acronym
RWE Retrospective Cardiovascular Outcome Study in Users of HTPs in Japan
Region
| Japan |
Condition
Condition
Non-fatal myocardial infarction, unstable angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to retrospectively evaluate the impact of having switched from CIG to exclusive use of HTPs (hereafter, exclusive HTP use) on time to first subsequent major adverse cardiovascular event (hereafter, MACE) compared with continued smoking of CIG (hereafter, exclusive CIG smoking), dual use of CIG and HTP, quitting of CIG (hereafter, former smoking), and never smoking in patients who have already experienced a first-ever (defined as first identified or first recorded in the Tokushukai Medical Database) cardiovascular event of non-fatal myocardial infarction (MI), unstable angina, or urgent coronary revascularization procedure (Index Event), after adjusting for sociodemographic and other risk factors.
Basic objectives2
Others
Basic objectives -Others
The primary outcome is about comparative effectiveness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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])
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
5490
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Tokushukai Medical Corporation Shonan-Fujisawa Tokushukai Hospital
Division name
Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Tsujidokandai, Fujisawa-shi, Kanagawa, Japan
TEL
0466-35-1177
m-hibino@ctmc.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sato |
Organization
Syneos Health Clinical K.K.
Division name
Clinical Operations/Real World and Late Phase
Zip code
100-7012
Address
12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6733-9690
Homepage URL
takashi.sato@syneoshealth.com
Sponsor or person
Institute
Philip Morris Products S.A.
Institute
Department
Personal name
Funding Source
Organization
Philip Morris Products S.A.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Switzerland
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳洲会グループ/ Tokushukai Group
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 29 | Day |
Other
Other related information
It is expected that there will be a difference in the time from Index Event to a first subsequent Broad Modified MACE between smokers who switched to exclusive use of HTP and those that continued to smoke CIG exclusively. The findings on the time from Index Event to a first subsequent Broad Modified MACE in exclusive HTP users compared to dual users of CIG and HTP, former smokers, or never smokers will also be reported. The results of the study will be released in the first quarter of 2026.
Management information
Registered date
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065853
