A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
NCT ID: NCT03344653
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2000 participants
INTERVENTIONAL
2017-11-02
2020-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
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.
Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
Interventions
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Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Windecker, MD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital, Bern, Switzerland
Azeem Latib, MD
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Scientific Institute, Milan, Italy
Elvin Kedhi, MD
Role: PRINCIPAL_INVESTIGATOR
Isala Zwolle, Netherlands
Locations
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Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Bundaberg Cardiology - Friendly Society Private Hospital
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Adelaide Cardiology
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Saint Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
LKH - Universitätsklinikum Graz
Graz, , Austria
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, , Austria
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, , Austria
C.H.U. de Charleroi
Charleroi, , Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, , Belgium
CHU de Liège - Hôpital du Sart Tilman
Liège, , Belgium
Acibadem City Clinic
Sofia, , Bulgaria
Clinique Axium
Aix-en-Provence, , France
Hôpital Privé Jacques Cartier
Massy, , France
Queen Elizabeth Hospital (Hong Kong)
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Galway University Hospitals - University Hospital Galway (UHG)
Galway, , Ireland
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate, Bergamo, Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, , Italy
San Raffaele Scientific Institute
Milan, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Umberto I - Policlinico di Roma
Roma, , Italy
Paula Stradina Kliniska universitates slimnica
Riga, , Latvia
Riga East University Hospital
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, Malaysia
Sarawak Heart Centre
Kuching, Sarawak, Malaysia
Hospital Serdang
Kajang, Selangor, Malaysia
Sarawak Heart Centre
Kota Kinabalu, , Malaysia
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, , Malaysia
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Zuyderland Medisch Centrum Heerlen
Heerlen, , Netherlands
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
HagaZiekenhuis - Locatie Leyweg
The Hague, , Netherlands
VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, , Netherlands
Isala Zwolle
Zwolle, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Wellington Hospital
Newtown, , New Zealand
Oslo Universitetssykehus-Ullevål Universitetssykehus
Oslo, , Norway
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, , Norway
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
Miedziowe Centrum Zdrowia
Lubin, , Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, , Poland
National University Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, , Slovakia
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Bellvitge
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Gävle sjukhus
Gävle, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Södersjukhuset
Stockholm, , Sweden
Karolinska University Hospital in Solna
Stockholm, , Sweden
Västmanlands Sjukhus
Västerås, , Sweden
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
Siriraj Hospital
Bangkok, , Thailand
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
Cardiff, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, , United Kingdom
Golden Jubilee National Hospital - NHS Trust
Glasgow, , United Kingdom
Royal Free Hospital
London, , United Kingdom
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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References
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Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
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.
Other Identifiers
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MDT17054RES007
Identifier Type: -
Identifier Source: org_study_id