Medtronic has initiated a new clinical study in patients implanted with its Resolute Onyx drug-eluting stent (DES) during percutaneous coronary intervention (PCI) procedures.
The Resolute Onyx DES secured the European CE-Mark and the US Food and Drug Administration (FDA) approval in September 2014 and April 2017, respectively.
The Onyx ONE Clear study will assess the use of one-month dual antiplatelet therapy (DAPT) in US and Japanese patients who are at high risk of bleeding.
DAPT is a combination of aspirin and an anti-clotting drug. The study will evaluate its safety, such as any potential cardiac risks, when used with a next-generation DES.
Onyx ONE Clear study co-principal investigator David Kandzari said: “This large-scale clinical study will help address an unmet need as high bleeding risk patients have been largely underrepresented in previous studies looking at shorter DAPT duration.”
This study is part of the Medtronic Onyx ONE Month DAPT Program, which also included a prior Onyx ONE Global Study. The DAPT programme is designed to recruit a total of about 2,700 patients across 140 clinical sites globally.
Onyx ONE Month DAPT Program chair Gregg Stone said: “One-month DAPT duration after coronary stenting in high bleeding risk patients offers the potential to substantially enhance the safety of interventional procedures in these high-risk patients.
“This study will provide insight as to whether one-month DAPT after Resolute Onyx in high bleeding risk patients is effective in minimising stent thrombosis and other complications, thereby reducing bleeding-related harm with prolonged anti-platelet therapy.”
Medtronic said that more than 20,000 patients in its clinical trials have addressed DAPT duration.