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Clinical Trials/NL-OMON50309
NL-OMON50309CompletedNot Applicable

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

Medtronic B.V.0 sites300 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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
  • •* 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
  • •* 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

Investigators

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