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

Stopped early · Phase 3

Conditions studied: Radial Artery Occlusion

In brief

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.

Key facts

Study ID

NCT03630055

Run by

Ottawa Heart Institute Research Corporation

People needed

930

Starts

2018-10-03

Expected to finish

2025-06-26

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 109/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 antiphosphopholipid antibody syndrome

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Kingston Health Sciences Center — Kingston, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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