Onyx ONE Study; A Randomized Controlled Trial with Resolute Onyx in One Month DAPT for High-Bleeding Risk Patients

Completed

• Conditions: angina pectoris; Ischemic heart disease; 10011082

• Registration Number: NL-OMON50309
• Lead Sponsor: Medtronic B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

All subjects who are acceptable candidates for treatment with a DES in
accordance with applicable guidelines for percutaneous coronary interventions,
per manufacturer*s Instructions for Use (and for Australia per IB) who
additionally meet pre-defined criteria for being high-bleeding risk and are
candidates for 1-month DAPT
To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject
must meet at least one of the following criteria, -Adjunctive 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 randomization) * 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 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 to prolonged DAPT for other medical reasons

Exclusion Criteria

* Subjects requiring a planned PCI procedure after one month of index procedure
* 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.
* Subjects with life expectancy of less than two years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the clinical safety of the Resolute Onyx stent as compared to the<br /><br>BioFreedom stent with use of 1month DAPT in subjects deemed at high risk for<br /><br>bleeding and/or medically unsuitable for more than 1 month DAPT treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the clinical effectiveness of the Resolute Onyx stent as compared<br /><br>to the BioFreedom stent with use of 1 month DAPT in subjects deemed at high<br /><br>risk for bleeding and/or medically unsuitable for more than 1 month DAPT<br /><br>treatment. </p><br>