A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
NCT ID: NCT03647475
Last Updated: 2021-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
752 participants
INTERVENTIONAL
2018-10-01
2021-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
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.
Interventions
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Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
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.
Eligibility Criteria
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Inclusion Criteria
* Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
* Age ≥ 75 years old
* Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
* Any prior documented intracerebral bleed
* Any documented stroke in the last 12 months
* Hospital admission for bleeding during the prior 12 months
* Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
* Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
* Planned surgery that would require interruption of DAPT (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
* Expected non-compliance for at least 6 months DAPT for other medical reasons
Exclusion Criteria
* Subjects requiring a planned PCI procedure after 1 month of index procedure
* Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
* Active bleeding at the time of inclusion
* Cardiogenic shock
* Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
* Subject not expected to comply with long-term single antiplatelet therapy
* 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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David Kandzari, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Atlanta Hospital, Atlanta, GA
Ajay Kirtane, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY
Locations
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Saint Joseph's Hospital Health Center
East Syracuse, New York, United States
New York- Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Countries
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References
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Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.
Kang J, Abdul Ghapar AK, Selvaraj K, Hur SH, Tam CC, Jang Y, Chae IH, Kandzari DE, Kirtane AJ, Latib A, Kedhi E, Lung TH, You SJ, Windecker S, Stone GW, Kim HS. One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary Intervention - Onyx ONE Clear 2-Year Results. Circ Rep. 2024 Jul 6;6(8):333-340. doi: 10.1253/circrep.CR-24-0037. eCollection 2024 Aug 9.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT18015RES008
Identifier Type: -
Identifier Source: org_study_id