Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization

NCT06812455 | Recruiting Phase 4

• 1 other identifier: 107/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery Occlusion

Keywords

radial artery occlusion; complications; transradial; coronary catheterization; treatment

Outcome Measures

Primary Outcomes (1)

• Radial artery patency

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

  4 weeks

Secondary Outcomes (1)

• Bleeding events

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Patients with RAO that will receive Rivaroxaban

Drug: Rivaroxaban

Control

NO INTERVENTION

Patients with RAO that will not receive any anticoagulation

Interventions

Rivaroxaban DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age \< 18 years
• Unable to provide informed written consent
• Any contraindication to receive Rivaroxaban

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

RECRUITING

Related Publications (5)

• Amirpour A, Zavar R, Seifipour A, Sadeghi M, Shirvani E, Kermani-Alghoraishi M, Sanei H, Hashemi Jazi SM, Pourmoghaddas A, Khosravi Farsani A, Zarepour E, Safaei A, Hassannejad R. Apixaban, a Novel Oral Anticoagulant, Use to Resolute Arterial Patency in Radial Artery Occlusion Due to Cardiac Catheterization; A Pilot Randomized Clinical Trial. ARYA Atheroscler. 2023 Nov-Dec;19(6):18-26. doi: 10.48305/arya.2023.41915.2909.

  PMID: 38883851 BACKGROUND

• Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.

  PMID: 31753298 BACKGROUND

• Tsigkas G, Papanikolaou A, Apostolos A, Kramvis A, Timpilis F, Latta A, Papafaklis MI, Aminian A, Davlouros P. Preventing and Managing Radial Artery Occlusion following Transradial Procedures: Strategies and Considerations. J Cardiovasc Dev Dis. 2023 Jun 30;10(7):283. doi: 10.3390/jcdd10070283.

  PMID: 37504539 BACKGROUND

• Didagelos M, Pagiantza A, Zegkos T, Papanastasiou C, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Sianos G, Karvounis H, Ziakas A. Low-molecular-weight heparin in radial artery occlusion treatment: the LOW-RAO randomized study. Future Cardiol. 2022 Feb;18(2):91-100. doi: 10.2217/fca-2021-0067. Epub 2021 Aug 16.

  PMID: 34397270 BACKGROUND

• Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.

  PMID: 35981848 BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Antonios Ziakas, Professor

  AHEPA University Hospital, Thessaloniki, Greece

  STUDY CHAIR

Central Study Contacts

Matthaios Didagelos, MD, MSc, PhD

CONTACT

2310994830; manthosdid@yahoo.gr

Areti Pagiantza, MD

CONTACT

2313303736; apayantza@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Interventional Cardiologist

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)