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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03344653
Registration number
NCT03344653
Ethics application status
Date submitted
20/10/2017
Date registered
17/11/2017
Titles & IDs
Public title
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
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Scientific title
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
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Secondary ID [1]
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MDT17054RES007
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Universal Trial Number (UTN)
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Trial acronym
Onyx ONE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Treatment: Devices - Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Active comparator: Resolute Onyx stent - Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
Active comparator: BioFreedom stent - Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
Treatment: Devices: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
Treatment: Devices: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
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Assessment method [1]
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Powered for non-inferiority against BioFreedom (control), is a composite of cardiac death, myocardial infarction and definite/probable stent thrombosis. The combined clinical outcome of cardiac death, MI or stent thrombosis
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Timepoint [1]
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1 year post-procedure
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Secondary outcome [1]
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Target Lesion Failure
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Assessment method [1]
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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
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Timepoint [1]
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2 year post-procedure
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Secondary outcome [2]
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Procedure Success
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Assessment method [2]
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Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
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Timepoint [2]
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2 year post-procedure
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Secondary outcome [3]
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Cardiac Death
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Assessment method [3]
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All deaths including cardiac death
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Timepoint [3]
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2 year post- procedure
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Secondary outcome [4]
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Major Cardiac Event
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Assessment method [4]
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Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
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Timepoint [4]
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2 year post- procedure
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Secondary outcome [5]
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Myocardial Infarction
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Assessment method [5]
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All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
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Timepoint [5]
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2 year post-procedure
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Secondary outcome [6]
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Target Vessel Failure
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Assessment method [6]
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Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
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Timepoint [6]
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2 year post-procedure
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Secondary outcome [7]
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Revascularization
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Assessment method [7]
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All revascularizations (TLR, TVR and non-TVR)
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Timepoint [7]
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2 year post-procedure
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Secondary outcome [8]
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Stent Thrombosis
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Assessment method [8]
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Stent thrombosis (per Academic Research Consortium (ARC) definition)
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Timepoint [8]
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2 year post-procedure
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Secondary outcome [9]
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Bleeding
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Assessment method [9]
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Bleeding per BARC criteria
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Timepoint [9]
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2 year post-procedure
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Secondary outcome [10]
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Stroke
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Assessment method [10]
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Stroke
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Timepoint [10]
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2 year post-procedure
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Secondary outcome [11]
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Lesion Success
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Assessment method [11]
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The attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
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Timepoint [11]
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2 year post-procedure
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Secondary outcome [12]
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Device success
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Assessment method [12]
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Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
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Timepoint [12]
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2 year post-procedure
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Eligibility
Key inclusion criteria
* Age = 75 years old
* Any prior documented intracerebral bleed
* Any documented stroke in the last 12 months
* Hospital admission for bleeding during the prior 12 months
* Non-skin cancer diagnosed or treated =3 years
* Planned surgery within the next 12 months
* Renal failure defined as: Creatinine clearance <40 ml/min
* Thrombocytopenia (PLT <100,000/mm3)
* Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnant and breastfeeding women
* Subjects requiring a planned PCI procedure after 1 month of index procedure
* Active bleeding at the time of inclusion
* Cardiogenic shock
* A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, 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.
* PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
* Participation in another clinical study within 12 months after index procedure
* Subjects with life expectancy of less than 2 years
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/10/2020
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Sample size
Target
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Accrual to date
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Final
2000
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal North Shore Hospital - Saint Leonards
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Royal Brisbane and Women's Hospital - Brisbane
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Bundaberg Cardiology - Friendly Society Private Hospital - Bundaberg
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Cairns Hospital - Cairns
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The Prince Charles Hospital - Chermside
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Princess Alexandra Hospital - Woolloongabba
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Adelaide Cardiology - Adelaide
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Flinders Medical Centre - Bedford Park
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Saint Vincent's Hospital (Melbourne) - Fitzroy
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The Alfred Hospital - Melbourne
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Recruitment hospital [11]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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4029 - Brisbane
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4670 - Bundaberg
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4870 - Cairns
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Recruitment postcode(s) [5]
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4032 - Chermside
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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5042 - Bedford Park
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Recruitment postcode(s) [10]
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3004 - Melbourne
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Recruitment postcode(s) [11]
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6150 - Murdoch
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Recruitment outside Australia
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Austria
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Graz
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Austria
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Innsbruck
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Wien
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Charleroi
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Belgium
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Leuven
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Liège
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Sofia
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Massy
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Bern
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Vascular
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
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Trial website
https://clinicaltrials.gov/study/NCT03344653
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Trial related presentations / publications
Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Kahar Bin Abdul Ghapar A, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Ali ZA, Parke M, Lung TH, Stone GW; Onyx ONE Investigators. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010. Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12. Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.
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Public notes
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Contacts
Principal investigator
Name
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Stephan Windecker, MD
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Address
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Bern University Hospital, Bern, Switzerland
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03344653