Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06812455

Effect of Rivaroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization

Led by AHEPA University Hospital · Updated on 2025-02-11

80

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying the effects of Rivaroxaban on treating radial artery occlusion (RAO) that occurs after cardiac catheterization procedures such as angiography and percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label study comparing patients who receive Rivaroxaban with those who do not receive any anticoagulation treatment. The study aims to assess whether Rivaroxaban improves the reopening (patency) of the radial artery at 4 weeks and to compare bleeding and other complications between the groups. Patients diagnosed with RAO through ultrasound after coronary catheterization will be randomly assigned to one of two groups: one group will receive oral Rivaroxaban 20 mg once daily for 4 weeks, while the other group will receive no anticoagulant treatment. The study will monitor patients with ultrasound evaluations of the radial artery at 1, 2, and 4 weeks after the procedure. Clinical assessments of artery patency using pulse palpation and specific tests will also be performed. During the study, participants will undergo ultrasound imaging and clinical evaluations to track artery patency and any bleeding complications using standard bleeding classification systems. Researchers will record data at regular intervals up to 4 weeks after the procedure. The primary outcome is the artery patency at 4 weeks, and secondary outcomes include bleeding events. The study is expected to continue until 2029, with ongoing monitoring of patient responses and safety.

CONDITIONS

Brief Title

Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing coronary catheterization (angiography or PCI) through the radial artery
  • Successful insertion of at least one radial artery sheath during the procedure
  • Radial artery occlusion confirmed by ultrasound
  • Ability to provide informed written consent
  • Both male and female patients
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Unable to provide informed written consent
  • Any contraindication to receiving Rivaroxaban treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 weeks

Participants diagnosed with radial artery occlusion will be randomized to receive Rivaroxaban or no anticoagulation for 4 weeks.

1 baseline visit and 3 follow-up visits at 1, 2, and 4 weeks

Trial Site Locations

Total: 1 location

1

AHEPA University Hospital

Thessaloniki, Greece, 54636

Actively Recruiting

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Research Team

M

Matthaios Didagelos, MD, MSc, PhD

A

Areti Pagiantza, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Apixaban, a Novel Oral Anticoagulant, Use to Resolute Arterial Patency in Radial Artery Occlusion Due to Cardiac Catheterization; A Pilot Randomized Clinical Trial.

Afshin Amirpour, Reihaneh Zavar, Amir Seifipour...

https://pubmed.ncbi.nlm.nih.gov/38883851

Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper.

Ivo Bernat, Adel Aminian, Samir Pancholy...

https://pubmed.ncbi.nlm.nih.gov/31753298

Preventing and Managing Radial Artery Occlusion following Transradial Procedures: Strategies and Considerations.

Grigorios Tsigkas, Amalia Papanikolaou, Anastasios Apostolos...

https://pubmed.ncbi.nlm.nih.gov/37504539

Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study.

Matthaios Didagelos, Areti Pagiantza, Thomas Zegkos...

https://pubmed.ncbi.nlm.nih.gov/35981848