A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

NCT03344653 | Completed DMC

• 1 other identifier: MDT17054RES007
• Study Type: interventional
• Target: 2,000
• Locations: 22 countries
• Sites: 78

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis

  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

  1 year post-procedure

Secondary Outcomes (12)

• Target Lesion Failure

  2 year post-procedure

• Procedure Success

  2 year post-procedure

• Cardiac Death

  2 year post- procedure

• Major Cardiac Event

  2 year post- procedure

• Myocardial Infarction

  2 year post-procedure

Study Arms (2)

Resolute Onyx stent

ACTIVE COMPARATOR

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.

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System

BioFreedom stent

ACTIVE COMPARATOR

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.

Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent

Interventions

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System DEVICE

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT

Resolute Onyx stent

Biosensors BioFreedom BA9 Drug Coated Coronary Stent DEVICE

Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

BioFreedom stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and breastfeeding women
• Subjects requiring a planned PCI procedure after 1 month of index procedure
• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (89)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Bundaberg Cardiology - Friendly Society Private Hospital

Bundaberg, Queensland, 4670, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Adelaide Cardiology

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Saint Vincent's Hospital (Melbourne)

Fitzroy, Victoria, 3065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

LKH - Universitätsklinikum Graz

Graz, 8036, Austria

Location

A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, 6020, Austria

Location

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, 1090, Austria

Location

C.H.U. de Charleroi

Charleroi, 6042, Belgium

Location

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

CHU de Liège - Hôpital du Sart Tilman

Liège, 4000, Belgium

Location

Acibadem City Clinic

Sofia, 1700, Bulgaria

Location

Clinique Axium

Aix-en-Provence, 13097, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Queen Elizabeth Hospital (Hong Kong)

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Galway University Hospitals - University Hospital Galway (UHG)

Galway, Ireland

Location

Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini

Seriate, Bergamo, 24068, Italy

Location

Presidio Ospedaliero Ferrarotto Alessi

Catania, 95124, Italy

Location

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Umberto I - Policlinico di Roma

Roma, 00161, Italy

Location

Paula Stradina Kliniska universitates slimnica

Riga, 1002, Latvia

Location

Riga East University Hospital

Riga, LV-1079, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50009, Lithuania

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Queen Elizabeth II Hospital

Kota Kinabalu, Sabah, 88300, Malaysia

Location

Sarawak Heart Centre

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

Location

Sarawak Heart Centre

Kota Kinabalu, 94300, Malaysia

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Zuyderland Medisch Centrum Heerlen

Heerlen, 6419 PC, Netherlands

Location

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, 6229 HX, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

HagaZiekenhuis - Locatie Leyweg

The Hague, 2545 CH, Netherlands

Location

VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo

Venlo, 5912 BL, Netherlands

Location

Isala Zwolle

Zwolle, 8025 AB, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Wellington Hospital

Newtown, 6021, New Zealand

Location

Oslo Universitetssykehus-Ullevål Universitetssykehus

Oslo, 0450, Norway

Location

Stavanger Universitetssjukehus - Helse Stavanger HF

Stavanger, 4011, Norway

Location

Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-635, Poland

Location

Miedziowe Centrum Zdrowia

Lubin, 59-301, Poland

Location

Szpital Kliniczny Przemienienia Panskiego

Poznan, 61-848, Poland

Location

National University Hospital

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

Banská Bystrica, 97401, Slovakia

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 220-701, South Korea

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Gävle sjukhus

Gävle, 801 88, Sweden

Location

Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Karolinska University Hospital in Solna

Stockholm, 171 76, Sweden

Location

Västmanlands Sjukhus

Västerås, 721 89, Sweden

Location

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Cardiff and Vale University Health Board - University Hospital of Wales (UHW)

Cardiff, CF14 4XW, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Golden Jubilee National Hospital - NHS Trust

Glasgow, G81 4HX, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

The James Cook University Hospital - South Tees Hospitals NHS

Middlesbrough, TS4 3BW, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 38626080 DERIVED

• 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.

  PMID: 37550123 DERIVED

• 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.

  PMID: 35680195 DERIVED

• 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.

  PMID: 32050061 DERIVED

• 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.

  PMID: 31203158 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stephan Windecker, MD

  Bern University Hospital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Azeem Latib, MD

  San Raffaele Scientific Institute, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Elvin Kedhi, MD

  Isala Zwolle, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 17, 2017
• Study Start: November 2, 2017
• Primary Completion: September 27, 2018
• Study Completion: October 9, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); BE (3); KR (9); BU (1); IT (5); NZ (4); SL (1); LA (2); MY (5); SG (2); LI (2); GB (8); ES (8); FR (2); HK (2); IE (1); NL (7); NO (2); TH (1); PL (3); CH (2); SE (5)