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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034936
Receipt No. 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 2018/11/19

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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
Middle name
Last name Isao Goto
Organization Cardiovascular Group (CVG)
Division name CSH Clinical
Zip code
Address 1-2-70 Konan , Minato-ku, Tokyo 108-0075
TEL 03-6776-0056
Email isao.goto@medtronic.com

Public contact
Name of contact person
1st name
Middle name
Last name Isao Goto
Organization Cardiovascular Group (CVG)
Division name CSH Clinical
Zip code
Address 1-2-70 Konan , Minato-ku, Tokyo 108-0075
TEL 03-6776-0056
Homepage URL
Email isao.goto@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 10 Day
Last follow-up date
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
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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