Using Rivaroxaban to treat radial artery occlusion after heart procedures
Effect of RIVAroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
PHASE4 · AHEPA University Hospital · NCT06812455
This study is testing if the blood thinner Rivaroxaban can help people with blocked radial arteries after heart procedures feel better and have fewer complications.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHEPA University Hospital (other) |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT06812455 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Rivaroxaban in treating radial artery occlusion (RAO) following cardiac catheterization procedures, including angiography and percutaneous coronary intervention (PCI). It is a prospective, single-center, randomized controlled trial where patients with RAO will be divided into two groups: one receiving Rivaroxaban and the other receiving no anticoagulation. The primary goal is to assess the patency rates of the radial artery at four weeks post-procedure, while secondary objectives include comparing complications at the access site and systemic complications. RAO will be diagnosed using radial artery ultrasound within 24 hours after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing coronary catheterization through the transradial access who have confirmed radial artery occlusion.
Not a fit: Patients under 18 years old or those with contraindications to Rivaroxaban will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the recovery of the radial artery function and reduce complications after cardiac catheterization.
How similar studies have performed: Previous studies have explored treatments for RAO, but this approach using Rivaroxaban is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thessaloniki
- AHEPA University Hospital — Thessaloniki, Greece (RECRUITING)
Study contacts
- Study coordinator: Matthaios Didagelos, MD, MSc, PhD
- Email: manthosdid@yahoo.gr
- Phone: 2310994830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radial Artery Occlusion, radial artery occlusion, complications, transradial, coronary catheterization, treatment