Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion

NCT03630055 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: 20180319
• Study Type: interventional
• Target: 930
• Locations: 2 countries
• Sites: 3

Brief Summary

Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in \~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.

Conditions

Radial Artery Occlusion

Keywords

Direct oral anticoagulants; Transradial access; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• Primary efficacy outcome - rate of radial artery occlusion

  Presence of radial artery occlusion at 30 days post-transradial access as determined by Doppler ultrasound assessment of the participant's radial artery in the wrist.

  30 days

• Primary safety outcome - International Society on Thrombosis and Haemostasis definition of major bleeding

  Bleeding as defined by the International Society on Thrombosis and Haemostasis at 30 days.

  30 days

Secondary Outcomes (11)

• All cause mortality

  30 days

• Stroke (ischemic or uncertain)

  30 days

• Stroke (hemorrhagic)

  30 days

• Fatal bleeding

  30 days

• Symptomatic bleeding in a critical area or organ

  30 days

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Participants will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days. Follow up will be within 30 days where participants will undergo a Doppler ultrasound to assess for radial artery patency/occlusion.

Drug: Rivaroxaban 15 MG Oral Tablet [Xarelto]

Standard of Care

NO INTERVENTION

Participants will not receive any anticoagulation. Follow up will be within 30 days where participants will undergo a Doppler ultrasound to assess for radial artery patency/occlusion.

Interventions

Rivaroxaban 15 MG Oral Tablet [Xarelto] DRUG

Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent
• Age ≥ 18 years
• Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach

You may not qualify if:

• Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
• Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein
• Planned staged procedure, CABG or noncardiac surgery within 30 days
• Contraindication or high risk of bleeding with anticoagulation
• bleeding requiring medical attention in the previous 6 months
• thrombocytopenia (platelets\<50 x 109/L)
• prior intracranial hemorrhage
• use of IIb/IIIa during percutaneous coronary intervention
• administration of thrombolytic therapy in the preceding 24 hours
• use of non-steroidal anti-inflammatory medications
• ischemic stroke or transient ischemic attack diagnosed in the last 3 months
• Cardiogenic shock
• Ventricular arrhythmias refractory to treatment
• Liver dysfunction (Child-Pugh class B or C)
• Unexplained anemia with a Hgb below 100 g/L

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Kingston Health Sciences Center

Kingston, Ontario, K7L 2V7, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (18)

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  PMID: 37173116 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases

Interventions

Rivaroxaban; Tablets

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will undergo a 1:1 randomization using a computer-generated randomization sequence to either receive a direct oral anticoagulant (i.e. rivaroxaban 15mg oral daily) for 7 days or to the standard of care arm (i.e. no rivaroxaban)

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 14, 2018
• Study Start: October 3, 2018
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: May 5, 2026

Record last verified: 2024-07

Locations

US (1); CA (2)