UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032916 |
|---|---|
| Receipt number | R000036293 |
| Scientific Title | CPAP Effects on Atherosclerotic Plaques in Patients with Sleep-Disordered Breathing and Coronary Artery Disease |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2024/06/11 10:47:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
CPAP Effects on Atherosclerotic Plaques in Patients with Sleep-Disordered Breathing and Coronary Artery Disease
Acronym
The ENTERPRISE trial
Scientific Title
CPAP Effects on Atherosclerotic Plaques in Patients with Sleep-Disordered Breathing and Coronary Artery Disease
Scientific Title:Acronym
The ENTERPRISE trial
Region
| Japan |
Condition
Condition
Patients with stable coronary artery disease and sleep-disordered breathing
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of adding CPAP treatment to optimal medical treatment on coronary plaque in patients with sleep-disordered breathing and coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage changes in plaque atheroma volume in the non-culprit lesion measured by IVUS from baseline to 12 months
Key secondary outcomes
(1) Absolute changes in maxLCBI4mm and maxLCBI10mm in the non-culprit lesion segment by NIRS analysis from baseline to 12 months
(2) Absolute change in total atheroma volume in the non-culprit lesion measured by IVUS from baseline to 12 months
(3) Absolute change in serum high-sensitivity C-reactive protein level from baseline to 12 months
(4) Major adverse cardiac and cerebrovascular events, defined as composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, target vessel revascularization including target lesion revascularization and non-target lesion target vessel revascularization and hospitalization for congestive heart failure, and all-cause death during the follow-up period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous positive airway pressure (CPAP) for 12 months
Interventions/Control_2
no-CPAP for 12 months
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed with stable coronary heart disease
2. Patients with 3%ODI >15 events/h
3. Successful PCI for significant coronary stenotic lesion under IVUS guidance
4. Patients having non-calcified plaque with maximal plaque burden > 40% of the non-culprit lesion segment detected by IVUS
5. Patients who agree to be enrolled in the trial, providing signed written informed consent
Key exclusion criteria
1. Patients treated with CPAP therapy
2. Patients with hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale [ESS] score >18)
3. Patients over 75 years of age
4. Patients with New York Heart Association class II, III, or IV heart failure
5. Patients with renal insufficiency (serum creatinine 2.0 mg/dL)
6. Patients with hemodialysis
7. Patients with malignant disease
8. Patients recognized as inadequate by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Dohi |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tdohi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Dohi |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tdohi@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Juntendo University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.journal-of-cardiology.com/article/S0914-5087%2818%2930219-3/fulltext
Publication of results
Unpublished
Result
URL related to results and publications
Submitted
Number of participants that the trial has enrolled
47
Results
Finally, the CPAP group (n=23) and non-CPAP group (n=24) were analyzed. Compared to the non-CPAP group, the CPAP group had a significantly decreased percentage atheroma volume (adjusted difference -2.81+/-1.10%, p=0.014) by analysis of covariance, and tended to have a lower incidence rate of MACCE, mainly driven by a decrease in target vessel revascularization (4% vs. 25%, p=0.097).
Results date posted
| 2024 | Year | 01 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean patient age was 62+/-8 years, and 96% of them were males. The prevalence of hypertension, diabetes mellitus, current smoking, family history of premature coronary artery disease, chronic kidney disease, and history of myocardial infarction were 94%, 64%, 21%, 13%, 19%, and 40%, respectively. The baseline clinical characteristics, including laboratory data, echographic data, medications and sleep parameters were similar between the CPAP group and non-CPAP groups.
Participant flow
53 patients with stable coronary artery disease who underwent PCI using NIRS-IVUS, coexisting with SDB was defined as a 3% oxygen desaturation index 15 events/hour or higher using pulse oximeter were recruited. The randomization was stratified using permuted blocked randomization,　according to the two stratification factors, as follows: body mass index less than 25 kg/m2 or 25 kg/m2 or higher and 3% oxygen desaturation index less than 30 events/hour or 30 events/hour or higher. Three patients in the CPAP group and three in the non-CPAP group discontinued during the follow-up period; therefore, 47 patients completed the study and were analyzed.
Adverse events
One patient felt dyspnea due to CPAP, and one patient developed gastric ulcer but no clear causal relationship with CPAP was observed.
Outcome measures
Compared to the non-CPAP group, the CPAP group had a significantly decreased percentage atheroma volume (adjusted difference -2.81+/-1.10%, p=0.014) by analysis of covariance, and tended to have a lower incidence rate of MACCE, mainly driven by a decrease in target vessel revascularization (4% vs. 25%, p=0.097). However, there was no significant difference in absolute change in maxLCBI4mm (0 [-32, 40] vs. 34 [-71, 163], p=0.312), absolute change in total atheroma volume (-4 [-30, 1] vs. -3 [-13, 8], p=0.170), and absolute change in serum high-sensitivity C-reactive protein levels between the two groups analyzed by Mann-Whitney U test, and no all-cause death was observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036293
