RECRUITING

Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in \~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.

Official Title

Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion

Quick Facts

Study Start:2018-10-03
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03630055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing and able to provide written informed consent
  2. 2. Age ≥ 18 years
  3. 3. Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach
  1. 1. Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
  2. 2. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein
  3. 3. Planned staged procedure, CABG or noncardiac surgery within 30 days
  4. 4. Contraindication or high risk of bleeding with anticoagulation
  5. 1. bleeding requiring medical attention in the previous 6 months
  6. 2. thrombocytopenia (platelets\<50 x 109/L)
  7. 3. prior intracranial hemorrhage
  8. 4. use of IIb/IIIa during percutaneous coronary intervention
  9. 5. administration of thrombolytic therapy in the preceding 24 hours
  10. 6. use of non-steroidal anti-inflammatory medications
  11. 7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months
  12. 5. Cardiogenic shock
  13. 6. Ventricular arrhythmias refractory to treatment
  14. 7. Liver dysfunction (Child-Pugh class B or C)
  15. 8. Unexplained anemia with a Hgb below 100 g/L
  16. 9. History of medication noncompliance or risk factor for noncompliance
  17. 10. Active malignancy
  18. 11. Allergy to rivaroxaban
  19. 12. Another indication for anticoagulation
  20. 13. CYP3A4 and P-glycoprotein inhibitor use
  21. 14. Life expectancy \<30 days
  22. 15. Women capable of pregnancy not on birth control
  23. 16. Chronic kidney disease with creatinine clearance of less than 30mL/min
  24. 17. History of antiphosphopholipid antibody syndrome

Contacts and Locations

Study Contact

Benjamin Hibbert, MD PhD
CONTACT
613-696-7280
bhibbert@ottawaheart.ca
Pietro Di Santo, MD
CONTACT
613-696-7280
pdisanto@ottawaheart.ca

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-03
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2018-10-03
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Direct oral anticoagulants
  • Transradial access
  • Percutaneous coronary intervention

Additional Relevant MeSH Terms

  • Radial Artery Occlusion