Using rivaroxaban to prevent radial artery occlusion after heart procedures
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
This study is testing if taking rivaroxaban for a week after heart procedures can help prevent problems with the radial artery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Trial ID | NCT03630055 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of rivaroxaban, a direct oral anticoagulant, in preventing radial artery occlusion (RAO) following transradial access during coronary angiography or percutaneous coronary intervention. Participants will receive a daily dose of 15mg of rivaroxaban for seven days post-procedure. The study aims to determine if this post-procedural anticoagulation can reduce the incidence of RAO, which is a common complication that limits future access to the radial artery. The trial is designed to provide insights into the safety and efficacy of this approach compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older undergoing diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.
Not a fit: Patients with a high risk of bleeding or those who have had recent complications at the access site may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of radial artery occlusion, improving future treatment options for patients requiring cardiac procedures.
How similar studies have performed: While the use of intraprocedural anticoagulation has shown promise, the specific approach of post-procedural anticoagulation with rivaroxaban is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Diagnostic coronary angiography 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 2. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein 3. Planned staged procedure, CABG or noncardiac surgery within 30 days 4. Contraindication or high risk of bleeding with anticoagulation 1. bleeding requiring medical attention in the previous 6 months 2. thrombocytopenia (platelets\<50 x 109/L) 3. prior intracranial hemorrhage 4. use of IIb/IIIa during percutaneous coronary intervention 5. administration of thrombolytic therapy in the preceding 24 hours 6. use of non-steroidal anti-inflammatory medications 7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months 5. Cardiogenic shock 6. Ventricular arrhythmias refractory to treatment 7. Liver dysfunction (Child-Pugh class B or C) 8. Unexplained anemia with a Hgb below 100 g/L 9. History of medication noncompliance or risk factor for noncompliance 10. Active malignancy 11. Allergy to rivaroxaban 12. Another indication for anticoagulation 13. CYP3A4 and P-glycoprotein inhibitor use 14. Life expectancy \<30 days 15. Women capable of pregnancy not on birth control 16. Chronic kidney disease with creatinine clearance of less than 30mL/min 17. History of antiphosphopholipid antibody syndrome
Where this trial is running
Rochester, Minnesota and 2 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Kingston Health Sciences Center — Kingston, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Benjamin Hibbert, MD PhD
- Email: bhibbert@ottawaheart.ca
- Phone: 613-696-7280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.