NCT06812455 Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization
| NCT ID | NCT06812455 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | AHEPA University Hospital |
| Condition | Radial Artery Occlusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2025-03-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Antonios Ziakas, Professor
STUDY CHAIR
AHEPA University Hospital, Thessaloniki, Greece
Frequently Asked Questions
Who can join the NCT06812455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radial Artery Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06812455 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06812455 currently recruiting?
Yes, NCT06812455 is actively recruiting participants. Contact the research team at manthosdid@yahoo.gr for enrollment information.
Where is the NCT06812455 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT06812455 clinical trial?
NCT06812455 is sponsored by AHEPA University Hospital. The principal investigator is Antonios Ziakas, Professor at AHEPA University Hospital, Thessaloniki, Greece. The trial plans to enroll 80 participants.