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.

“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.”

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.”

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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.