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Recruiting Phase 4 NCT06812455

Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization

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Trial Parameters

Condition Radial Artery Occlusion
Sponsor AHEPA University Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-01
Completion 2028-03-01
Interventions
Rivaroxaban

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Brief Summary

The purpose of the RIVA-RAO study is to determine whether the use of Rivaroxaban is an effective treatment of radial artery occlusion (RAO) after cardiac catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving Rivaroxaban and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure. Study objectives: Primary objective: To evaluate the effect of treatment with Rivaroxaban, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 4 weeks after the procedure, compared with no-anticoagulation treatment. Secondary objectives: To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 4 weeks after the procedure between the two groups.

Eligibility Criteria

Inclusion Criteria: 1. Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure 2. Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour) Exclusion Criteria: 1. Age \< 18 years 2. Unable to provide informed written consent 3. Any contraindication to receive Rivaroxaban

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