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

Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in ~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Drug: Rivaroxaban

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sarah R Devamani; Phone Number: (507) 255-0876; Email: Devamani.Sarah@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Principal Investigator: Trevor Simard, MD
      • Contact: Sarah Devamani; Phone Number: 507-255-0876; Email: devamani.sarah@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

Exclusion Criteria

• Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site in which bleeding risk would be prohibitive
• Access or attempted access site - including contralateral radial artery, brachial artery, or femoral artery or vein as switching of access could be attributed to arterial injury
• Planned staged procedure, coronary artery bypass grafting or noncardiac surgery, within 30 days
• Pregnant or lactating females

• 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. any prior intracranial hemorrhage
  4. use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention
  5. administration of thrombolytic therapy in the preceding 24 hours
  6. use of regular non-steroidal anti-inflammatory medications excluding Aspirin <100mg/day
  7. 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
• History of medication noncompliance or risk factor for noncompliance
• Active malignancy
• Allergy to rivaroxaban
• Another indication for anticoagulation
• Strong CYP3A4 and P-glycoprotein inhibitor use which increase rivaroxaban levels (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, diltiazem, verapamil and conivaptan, carbamazepine, phenytoin, rifampin, St.John's wort)
• Life expectancy <30 days
• Women capable of pregnancy not on birth control
• Chronic kidney disease with creatinine clearance of less than 30mL/min
• History of antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban Group; Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.	Drug: Rivaroxaban; 15mg oral daily for 7 days
No Intervention: Standard of Care Group; Subjects will receive the usual standard of care following transradial access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Outcome - Radial Artery Occlusion	Number of subjects to have a radial artery occlusion (RAO) at 30 days post-transradial access (TRA) as determined by Doppler ultrasound assessment.	30 days
Primary Safety Outcome - Major Bleeding	Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Trevor Simard, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 21-006724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No