Clinical trial NCT03344653: A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Official title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
timeFrame: 1 year post-procedure
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 2 year post-procedure
measure: Procedure Success
timeFrame: 2 year post-procedure
measure: Cardiac Death
timeFrame: 2 year post- procedure
measure: Major Cardiac Event
timeFrame: 2 year post- procedure
measure: Myocardial Infarction
timeFrame: 2 year post-procedure
measure: Target Vessel Failure
timeFrame: 2 year post-procedure
measure: Revascularization
timeFrame: 2 year post-procedure
measure: Stent Thrombosis
timeFrame: 2 year post-procedure
measure: Bleeding
timeFrame: 2 year post-procedure
measure: Stroke
timeFrame: 2 year post-procedure
measure: Lesion Success
timeFrame: 2 year post-procedure
measure: Device success
timeFrame: 2 year post-procedure
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Bundaberg
country: Australia
facility: Bundaberg Cardiology - Friendly Society Private Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Cardiology
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Fitzroy
country: Australia
facility: Saint Vincent's Hospital (Melbourne)
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Graz
country: Austria
facility: LKH - Universitätsklinikum Graz
city: Innsbruck
country: Austria
facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus - Universitätskliniken Wien
city: Charleroi
country: Belgium
facility: C.H.U. de Charleroi
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Liège
country: Belgium
facility: CHU de Liège - Hôpital du Sart Tilman
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital (Hong Kong)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Galway
country: Ireland
facility: Galway University Hospitals - University Hospital Galway (UHG)
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
state: Bergamo
city: Catania
country: Italy
facility: Presidio Ospedaliero Ferrarotto Alessi
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Roma
country: Italy
facility: Umberto I - Policlinico di Roma
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Riga
country: Latvia
facility: Paula Stradina Kliniska universitates slimnica
city: Riga
country: Latvia
facility: Riga East University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth II Hospital
state: Sabah
city: Kuching
country: Malaysia
facility: Sarawak Heart Centre
state: Sarawak
city: Kajang
country: Malaysia
facility: Hospital Serdang
state: Selangor Darul Ehsan
city: Kota Kinabalu
country: Malaysia
facility: Sarawak Heart Centre
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara - National Heart Institute
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum Heerlen
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
city: Zwolle
country: Netherlands
facility: Isala Zwolle
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Ullevål Universitetssykehus
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus - Helse Stavanger HF
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Gävle
country: Sweden
facility: Gävle sjukhus
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital in Solna
city: Västerås
country: Sweden
facility: Västmanlands Sjukhus
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital - NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital - South Tees Hospitals NHS
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Bern University Hospital, Bern, Switzerland
name: Stephan Windecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Scientific Institute, Milan, Italy
name: Azeem Latib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala Zwolle, Netherlands
name: Elvin Kedhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.