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

Radial Artery Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399277
• Other study ID #: 21-006724
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: Sarah R Devamani
• Phone: (507) 255-0876
• Email: Devamani.Sarah[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Radial Artery Occlusion

Intervention

Drug:
• Rivaroxaban
15mg oral daily for 7 days

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	All-Cause Mortality	Death from any cause as determined by the treating physician	30 days
Secondary	Stroke (ischemic or uncertain)	Stroke (ischemic or uncertain) as defined by a treating neurologist	30 days
Secondary	Stroke (hemorrhagic)	Stroke (hemorrhagic) as defined by a treating neurologist	30 days
Secondary	Fatal bleeding	Bleeding resulting in death as defined by treating physician	30 days
Secondary	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
Secondary	Bleeding requiring medical attention	Any bleeding that requires participant to seek medical attention	30 days
Secondary	GUSTO bleeding criteria	Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	30 days
Secondary	TIMI bleeding criteria	Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria	30 days
Secondary	BARC bleeding criteria	Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria	30 days
Secondary	Myocardial infarction	Myocardial infarction as defined by the third universal definition of myocardial infarction.	30 days
Secondary	Stent thrombosis	Stent thrombosis as determined by the academic research consortium criteria.	30 days

External Links

•   Mayo Clinic Clinical Trials