Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in ~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. We will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Ottawa Heart Institute Research Corporation
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent.

• Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.

Exclusion Criteria:

• Individuals < 18 years old.

• Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site

• Unsuccessful or abandoned attempt at a secondary arterial access site

• 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 10^9/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 hemoglobin below 10 g/dL.

• 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 antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).