Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization

ConditionRadial Artery Occlusion

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorAHEPA University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)

Disqualifiers

Age < 18 years

Unable to provide informed written consent

Any contraindication to receive Rivaroxaban

Trial design

Design model

Parallel

Treatments tested in this trial

Rivaroxaban
Drug
Patients with RAO that will receive p.o. tabs Rivaroxaban 20 mg q.d.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Radial artery patency

Radial artery patency at 4 weeks after the procedure, evaluated with radial artery ultrasound.

Time frame

4 weeks

Secondary outcomes

Bleeding events

To compare bleeding events (based on the BARC bleeding definition) at 4 weeks after the procedure.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AHEPA University Hospital

Lead sponsor

Source ClinicalTrials.gov

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