UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034936 |
|---|---|
| Receipt number | R000039835 |
| Scientific Title | Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2025/02/11 12:22:04 |
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Basic information
Public title
Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
Acronym
Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
Scientific Title
Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
Scientific Title:Acronym
Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
Region
| Japan | North America |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment with respect to a composite endpoint rate of cardiac death and myocardial infarction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [time frame: one month to one year]
Key secondary outcomes
The following will be assessed at all follow-up time points (1, 2, 6 months, 1 and 2 years), except acute success:
Acute success (device, lesion, procedure)
All deaths, including cardiac death
Major adverse cardiac event (MACE)
Defined as death, myocardial infarction, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods
Composite of cardiac death and myocardial infarction
Target vessel failure (TVF)
Defined as cardiac death, target vessel myocardial infarction or clinically-driven target vessel revascularization
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel
Cardiac death not clearly due to a non-target vessel endpoint
Target vessel revascularization is determined
Target lesion failure (TLF)
Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.
All revascularizations (TLR, TVR and non-TVR)
Stent thrombosis (def/prob)
Stroke
Bleeding per BARC criteria
BARC 3 to 5
BARC 2 to 5
All BARC
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MDT 2118 stent is placed in subjects who are acceptable candidates for treatment with a drug eluting stent in accordance with applicable guidelines for percutaneous coronary interventions, who additionally meet pre-defined criteria for being high-bleeding risk and/or are candidates for 1-month DAPT.
After that, 1 month of DAPT therapy and 1 month after SAPT therapy are carried out.
Antiplatelet medication dosing, should be administered per hospital routine and in line with applicable guidelines on percutaneous coronary interventions and the IFU of the device.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All subjects who are acceptable candidates for treatment with a DES in accordance with applicable guidelines for percutaneous coronary interventions, per manufacturer is Instructions for Use, who additionally meet pre-defined criteria for being high-bleeding risk and/or are candidates for 1-month DAPT and in the opinion of the investigator, the potential benefit of 1-month DAPT to the subject outweighs the potential risk.
To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject must meet at least one of the following criteria:
1) Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
2) Age >= 75 years old
3) Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
4) Any prior documented intracerebral bleed
5) Any documented stroke in the last 12 months
6) Hospital admission for major bleeding during the prior 12 months
7) Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
8) Planned daily NSAID (other than aspirin) or steroids for >= 30 days after PCI
9) Planned surgery that would require interruption of DAPT (within the next 12 months)
10) Renal failure defined as Creatinine clearance <40 ml/min
11) Thrombocytopenia (PLT <100,000/mm3)
12) Severe chronic liver disease defined as subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13) Expected non-compliance for at least 6 months DAPT for other medical reasons
Key exclusion criteria
1) Pregnant and breastfeeding women
2) Subjects requiring a planned PCI procedure after one month of index procedure
3) Procedure planned to require non-study stents, stand-alone POBA, or stand-alone atherectomy
4) Active bleeding at the time of inclusion
5) Cardiogenic shock
6) Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
7) Subject not expected to comply with long-term single antiplatelet therapy
8) A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g., BioLinx), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
9) PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
10) Participation in another clinical study within 12 months after index procedure
11) Subjects with life expectancy of less than 2 years
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Shiomitsu |
Organization
Japan Clinical Research and Medical Science
Division name
Clinical Research
Zip code
108-0075
Address
1-2-70 Konan , Minato-ku, Tokyo 108-0075
TEL
080-7092-0518
aki.shiomitsu@medtronic.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Shiomitsu |
Organization
Japan Clinical Research and Medical Science
Division name
Clinical Research
Zip code
108-0075
Address
1-2-70 Konan , Minato-ku, Tokyo 108-0075
TEL
080-7092-0518
Homepage URL
aki.shiomitsu@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu-shi, Fukuoka 802-8555
Tel
093-511-2000
crc@kokurakinen.or.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
湘南鎌倉総合病院（神奈川県）、帝京大学医学部附属病院（東京都）、東海大学医学部付属病院（神奈川県）、済生会熊本病院（熊本県）、小倉記念病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/study/NCT03647475?term=Onyx%20One%20Clear&rank=1
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33167705/
Number of participants that the trial has enrolled
752
Results
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).
Results date posted
| 2025 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).
Participant flow
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).
Adverse events
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).
Outcome measures
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039835
