NCT Number: NCT06812455
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Thessaloniki, 54636, Greece
Location status: Recruiting
Antonios Ziakas, Professor
PRINCIPAL_INVESTIGATOR
Areti Pagiantza, MD
CONTACT
2313303736 ext. +30
Areti Pagiantza, MD
PRINCIPAL_INVESTIGATOR
Matthaios Didagelos, MD, MSc, PhD
PRINCIPAL_INVESTIGATOR
The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safer hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound).
Although perceived as usually asymptomatic, RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting.
Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today the only randomized studies reagrding RAO treatment have used either low-molecular-weight-heparin (LMWH) or apixaban.
This is a prospective, randomized study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after 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.
RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients.
Patients diagnosed with RAO will be randomized 1:1 into two groups:
Treatment group, that will receive Rivaroxaban for 4 weeks. Control group, that will not receive any anticoagulation.
All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with RAO that will receive p.o. tabs Rivaroxaban 20 mg q.d.
Time frame: 4 weeks
Radial artery patency at 4 weeks after the procedure, evaluated with radial artery ultrasound.
Time frame: 4 weeks
To compare bleeding events (based on the BARC bleeding definition) at 4 weeks after the procedure.
Contact information is provided by the study sponsor or research team.
Areti Pagiantza, MD
CONTACT
2313303736 ext. +30
Matthaios Didagelos, MD, MSc, PhD
CONTACT
2310994830 ext. +30
AHEPA University Hospital
Other
Effect of RIVAroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
Acronym: RIVA-RAO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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