Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)

May 10, 2023 updated by: Ottawa Heart Institute Research Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Assessment of the coronary artery anatomy is commonly performed by coronary angiography (CA), which is the gold standard for evaluation of obstructive coronary artery disease (CAD). Coronary revascularization, opening of obstructed vessels, is most commonly performed by percutaneous coronary intervention (PCI) in patients with obstructive CAD. Traditionally, PCI is performed with implantation of one or more permanent metallic stents which act as a scaffold for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for delivery of anti-proliferative agents. The transradial access (TRA) has rapidly emerged as the preferred vascular access site for CA and PCI with more than 50% of all coronary angiograms being performed via this approach.

There are several advantages to TRA for angiography including rapid hemostasis, early ambulation after the procedure thereby improving patient comfort and experience, and a decrease in the length of hospital stay. There is also a reported reduction in all-cause mortality, major adverse cardiovascular events, major bleeding, and vascular complications with TRA as compared to transfemoral access. However, radial artery occlusion (RAO) remains an important complication of this procedure as it precludes the reuse of this artery for future transradial approaches as well as the use of the vessel as a conduit for coronary artery bypass grafting.

Reports of RAO post-TRA has varied in the literature from ~4-10% in observational and randomized trials. In the largest systematic review published to date, the overall rate of RAO was 5.2% amongst the 46,631 subjects across 92 studies between 1989 and 2016. This systematic review also noted that the rate of early (i.e. <7 days) vs. late (i.e. >7 days) RAO was significantly higher which is suggestive of late recanalization in some patients. The factors which affect recanalization are not clear however standard of care involves administration of heparin during the procedure and patent hemostasis following the procedure. Patent hemostasis is performed by applying a delicate balance of pressure to prevent bleeding but not to the point of completely occlude the blood vessel and cessation of blood flow distally.

Numerous trials have explored the role of anticoagulation during angiography to reduce RAO and a recently published systematic review and meta-analysis demonstrated more intensive anticoagulation is protective. Indeed, this remains an active area of research with numerous ongoing trials evaluating the effect of intensive or higher dose anticoagulation during the procedure for prevention of RAO. Additionally, there were higher rates of RAO with diagnostic angiography as opposed to PCI purportedly as the latter involves higher doses of anticoagulation.

Direct oral anticoagulant (DOAC) therapy has provided a safer alternative with an improved bleeding profile over vitamin K antagonist anticoagulation therapy. The use of DOACs in cardiovascular medicine ranges from various conditions including stroke prevention in atrial fibrillation7-12 to venous thromboembolism13-16 to stable cardiovascular disease.

While intraprocedural anticoagulation has been studied extensively, a course of anticoagulation therapy post-TRA has not been studied. 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 RAO. Should this study prove to be positive, this could impact our routine standard of care with respect to having a strategy which could reduce the rate of this complication thereby preserving the radial artery for future access and/or as a conduit for coronary artery bypass grafting.

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Center
        • Contact:
          • Brigita Zile, RN
          • Phone Number: 7109 613-549-6666
        • Principal Investigator:
          • Joseph Abunassar, MD
      • Ottawa, Ontario, Canada, K1Y4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
          • Benjamin Hibbert, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
  2. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein
  3. Planned staged procedure, CABG or noncardiac surgery within 30 days

  4. Contraindication or high risk of bleeding with anticoagulation

    1. bleeding requiring medical attention in the previous 6 months
    2. thrombocytopenia (platelets<50 x 109/L)
    3. prior intracranial hemorrhage
    4. use of IIb/IIIa during percutaneous coronary intervention
    5. administration of thrombolytic therapy in the preceding 24 hours
    6. use of non-steroidal anti-inflammatory medications
    7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months
  5. Cardiogenic shock
  6. Ventricular arrhythmias refractory to treatment
  7. Liver dysfunction (Child-Pugh class B or C)
  8. Unexplained anemia with a Hgb below 100 g/L
  9. History of medication noncompliance or risk factor for noncompliance
  10. Active malignancy
  11. Allergy to rivaroxaban
  12. Another indication for anticoagulation
  13. CYP3A4 and P-glycoprotein inhibitor use
  14. Life expectancy <30 days
  15. Women capable of pregnancy not on birth control
  16. Chronic kidney disease with creatinine clearance of less than 30mL/min
  17. History of antiphosphopholipid antibody syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban
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]
Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.
Other Names:
  • Xarelto
No Intervention: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary efficacy outcome - rate of radial artery occlusion
Time Frame: 30 days
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
Time Frame: 30 days
Bleeding as defined by the International Society on Thrombosis and Haemostasis at 30 days.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 30 days
Death from any cause as determined by the treating physician
30 days
Stroke (ischemic or uncertain)
Time Frame: 30 days
Stroke (ischemic or uncertain) as defined by a treating neurologist
30 days
Stroke (hemorrhagic)
Time Frame: 30 days
Stroke (hemorrhagic) as defined by a treating neurologist
30 days
Fatal bleeding
Time Frame: 30 days
Bleeding resulting in death as defined by treating physician
30 days
Symptomatic bleeding in a critical area or organ
Time Frame: 30 days
Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome
30 days
Bleeding requiring medical attention
Time Frame: 30 days
Any bleeding that requires participant to seek medical attention
30 days
GUSTO bleeding criteria
Time Frame: 30 days
Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
30 days
TIMI bleeding criteria
Time Frame: 30 days
Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
30 days
BARC bleeding criteria
Time Frame: 30 days
Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
30 days
Myocardial infarction
Time Frame: 30 days
Myocardial infarction as defined by the third universal definition of myocardial infarction.
30 days
Stent thrombosis
Time Frame: 30 days
Stent thrombosis as determined by the academic research consortium criteria.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Anticipated)

December 30, 2025

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180319

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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