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:

  1. Willing and able to provide written informed consent
  2. Age ≥ 18 years
  3. Diagnostic coronary angiography/left heart catheterization or percutaneous coronary intervention via the transradial approach

Exclusion Criteria:

  1. Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site in which bleeding risk would be prohibitive
  2. Access or attempted access site – including contralateral radial artery, brachial artery, or femoral artery or vein as switching of access could be attributed to arterial injury
  3. Planned staged procedure, coronary artery bypass grafting or noncardiac surgery, within 30 days
  4. Pregnant or lactating females
  5. Contraindication or high risk of bleeding with anticoagulation
    1. bleeding requiring medical attention in the previous 6 months
    2. thrombocytopenia (platelets < 50 x 10^9/L)
    3. any prior intracranial hemorrhage
    4. use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention
    5. administration of thrombolytic therapy in the preceding 24 hours
    6. use of regular non-steroidal anti-inflammatory medications excluding Aspirin < 100mg/day
    7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months
  6. Cardiogenic shock
  7. Ventricular arrhythmias refractory to treatment
  8. Liver dysfunction (Child-Pugh class B or C)
  9. Unexplained anemia with a Hgb below 100 g/L
  10. History of medication noncompliance or risk factor for noncompliance
  11. Active malignancy
  12. Allergy to rivaroxaban
  13. Another indication for anticoagulation
  14. Strong CYP3A4 and P-glycoprotein inhibitor use which increase rivaroxaban levels (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, diltiazem, verapamil and conivaptan, carbamazepine, phenytoin, rifampin, St.John’s wort)
  15. Life expectancy <30 days
  16. Women capable of pregnancy not on birth control
  17. Chronic kidney disease with creatinine clearance of less than 30mL/min
  18. History of antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/22/23. Questions regarding updates should be directed to the study team contact.

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.

Open for enrollment

Contact information:

Ischemic Heart Disease (IHD)

(507) 284-4256

More information

Publications

Publications are currently not available