Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rivaroxaban Group Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access. |
Drug: Rivaroxaban
15mg oral daily for 7 days
|
| No Intervention: Standard of Care Group Subjects will receive the usual standard of care following transradial access. |
Outcome Measures
Primary Outcome Measures
- Primary Efficacy Outcome - Radial Artery Occlusion [30 days]
Number of subjects to have a radial artery occlusion (RAO) at 30 days post-transradial access (TRA) as determined by Doppler ultrasound assessment.
- Primary Safety Outcome - Major Bleeding [30 days]
Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)
Secondary Outcome Measures
- All-Cause Mortality [30 days]
Death from any cause as determined by the treating physician
- Stroke (ischemic or uncertain) [30 days]
Stroke (ischemic or uncertain) as defined by a treating neurologist
- Stroke (hemorrhagic) [30 days]
Stroke (hemorrhagic) as defined by a treating neurologist
- Fatal bleeding [30 days]
Bleeding resulting in death as defined by treating physician
- Symptomatic bleeding in a critical area or organ [30 days]
Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome
- Bleeding requiring medical attention [30 days]
Any bleeding that requires participant to seek medical attention
- GUSTO bleeding criteria [30 days]
Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
- TIMI bleeding criteria [30 days]
Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
- BARC bleeding criteria [30 days]
Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
- Myocardial infarction [30 days]
Myocardial infarction as defined by the third universal definition of myocardial infarction.
- Stent thrombosis [30 days]
Stent thrombosis as determined by the academic research consortium criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to provide written informed consent.
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Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.
Exclusion Criteria:
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Individuals < 18 years old.
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Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
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Unsuccessful or abandoned attempt at a secondary arterial access site
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Planned staged procedure, CABG or noncardiac surgery within 30 days
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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.
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Cardiogenic shock.
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Ventricular arrhythmias refractory to treatment.
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Liver dysfunction (Child-Pugh class B or C).
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Unexplained anemia with hemoglobin below 10 g/dL.
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History of medication noncompliance or risk factor for noncompliance.
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Active malignancy.
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Allergy to rivaroxaban.
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Another indication for anticoagulation.
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CYP3A4 and P-glycoprotein inhibitor use.
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Life expectancy < 30 days.
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Women capable of pregnancy not on birth control.
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Chronic kidney disease with creatinine clearance of less than 30mL/min.
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History of antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- Ottawa Heart Institute Research Corporation
Investigators
- Principal Investigator: Trevor Simard, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-006724