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

Study Overview
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Brief Summary
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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. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.

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

Conditions
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Radial Artery Occlusion

Intervention / Treatment
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* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban Group<br>Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access. | Drug: Rivaroxaban<br>* 15mg oral daily for 7 days<br>|
| No Intervention: Standard of Care Group<br>Subjects will receive the usual standard of care following transradial access. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Outcome - Radial Artery Occlusion | Number of subjects to have a radial artery occlusion (RAO) at 30 days post-transradial access (TRA) as determined by Doppler ultrasound assessment. | 30 days | 
| Primary Safety Outcome - Major Bleeding | Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | Death from any cause as determined by the treating physician | 30 days | 
| Stroke (ischemic or uncertain) | Stroke (ischemic or uncertain) as defined by a treating neurologist | 30 days | 
| Stroke (hemorrhagic) | Stroke (hemorrhagic) as defined by a treating neurologist | 30 days | 
| Fatal bleeding | Bleeding resulting in death as defined by treating physician | 30 days | 
| Symptomatic bleeding in a critical area or organ | Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome | 30 days | 
| Bleeding requiring medical attention | Any bleeding that requires participant to seek medical attention | 30 days | 
| GUSTO bleeding criteria | Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | 30 days | 
| TIMI bleeding criteria | Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria | 30 days | 
| BARC bleeding criteria | Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria | 30 days | 
| Myocardial infarction | Myocardial infarction as defined by the third universal definition of myocardial infarction. | 30 days | 
| Stent thrombosis | Stent thrombosis as determined by the academic research consortium criteria. | 30 days |