Rivaroxaban Post-Transradial Access For The Prevention Of Radial Artery Occlusion

Overview

About this study

The purpose of this study is to answer the question: “Does a short course of oral anticoagulation with a direct oral anticoagulant after transradial access for coronary angiography/left heart catheterization and/or percutaneous coronary intervention reduce the incidence of radial artery occlusion?” The hypothesis is that oral anticoagulation will reduce the incidence of radial artery occlusion at 30 days without a significant increase in the rate of clinically significant bleeding.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Age ≥ 18 years.
  • Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.

Exclusion Criteria:

  • Individuals < 18 years old.
  • Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
  • Access or attempted access at a second site – including contralateral radial artery, brachial, or femoral artery or vein
  • Planned staged procedure, CABG or noncardiac surgery within 30 days
  • Contraindication or high risk of bleeding with anticoagulation:
    • bleeding requiring medical attention in the previous 6 months;
    • thrombocytopenia (platelets < 50 x 10^9/L);
    • prior intracranial hemorrhage;
    • use of IIb/IIIa during percutaneous coronary intervention;
    • administration of thrombolytic therapy in the preceding 24 hours;
    • use of non-steroidal anti-inflammatory medications;
    • ischemic stroke or transient ischemic attack diagnosed in the last 3 months.
  • Cardiogenic shock.
  • Ventricular arrhythmias refractory to treatment.
  • Liver dysfunction (Child-Pugh class B or C).
  • Unexplained anemia with a Hgb below 100 g/L.
  • History of medication noncompliance or risk factor for noncompliance.
  • Active malignancy.
  • Allergy to rivaroxaban.
  • Another indication for anticoagulation.
  • CYP3A4 and P-glycoprotein inhibitor use.
  • Life expectancy < 30 days.
  • Women capable of pregnancy not on birth control.
  • Chronic kidney disease with creatinine clearance of less than 30mL/min.
  • History of antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Trevor Simard, M.D., Ph.D.

Closed for enrollment

Contact information:

Ischemic Heart Disease (IHD)

(507) 284-4256

More information

Publications

Publications are currently not available