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

Phase 3

Recruiting

• Conditions: Radial Artery Occlusion
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT05399277
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2023-05-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban Group	Rivaroxaban	Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	30 days	Myocardial infarction as defined by the third universal definition of myocardial infarction.
Stroke (ischemic or uncertain)	30 days	Stroke (ischemic or uncertain) as defined by a treating neurologist
BARC bleeding criteria	30 days	Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
All-Cause Mortality	30 days	Death from any cause as determined by the treating physician
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
Stent thrombosis	30 days	Stent thrombosis as determined by the academic research consortium criteria.
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
Stroke (hemorrhagic)	30 days	Stroke (hemorrhagic) as defined by a treating neurologist
TIMI bleeding criteria	30 days	Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States