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

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Rivaroxaban

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