search
Back to results

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

Primary Purpose

Radial Artery Occlusion

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rivaroxaban
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radial Artery Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.

Exclusion Criteria:

  • Individuals < 18 years old.
  • Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site
  • Unsuccessful or abandoned attempt at a secondary arterial access site
  • 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 10^9/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 hemoglobin below 10 g/dL.
  • History of medication noncompliance or risk factor for noncompliance.
  • Active malignancy.
  • Allergy to rivaroxaban.
  • Another indication for anticoagulation.
  • CYP3A4 and P-glycoprotein inhibitor use.
  • 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).

Sites / Locations

  • Mayo Clinic RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rivaroxaban Group

Standard of Care Group

Arm Description

Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.

Subjects will receive the usual standard of care following transradial access.

Outcomes

Primary Outcome Measures

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.
Primary Safety Outcome - Major Bleeding
Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2022
Last Updated
June 6, 2023
Sponsor
Mayo Clinic
Collaborators
Ottawa Heart Institute Research Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05399277
Brief Title
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)
Official Title
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Ottawa Heart Institute Research Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Occlusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban Group
Arm Type
Experimental
Arm Description
Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Subjects will receive the usual standard of care following transradial access.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
15mg oral daily for 7 days
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome - Radial Artery Occlusion
Description
Number of subjects to have a radial artery occlusion (RAO) at 30 days post-transradial access (TRA) as determined by Doppler ultrasound assessment.
Time Frame
30 days
Title
Primary Safety Outcome - Major Bleeding
Description
Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All-Cause Mortality
Description
Death from any cause as determined by the treating physician
Time Frame
30 days
Title
Stroke (ischemic or uncertain)
Description
Stroke (ischemic or uncertain) as defined by a treating neurologist
Time Frame
30 days
Title
Stroke (hemorrhagic)
Description
Stroke (hemorrhagic) as defined by a treating neurologist
Time Frame
30 days
Title
Fatal bleeding
Description
Bleeding resulting in death as defined by treating physician
Time Frame
30 days
Title
Symptomatic bleeding in a critical area or organ
Description
Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome
Time Frame
30 days
Title
Bleeding requiring medical attention
Description
Any bleeding that requires participant to seek medical attention
Time Frame
30 days
Title
GUSTO bleeding criteria
Description
Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Time Frame
30 days
Title
TIMI bleeding criteria
Description
Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
Time Frame
30 days
Title
BARC bleeding criteria
Description
Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
Time Frame
30 days
Title
Myocardial infarction
Description
Myocardial infarction as defined by the third universal definition of myocardial infarction.
Time Frame
30 days
Title
Stent thrombosis
Description
Stent thrombosis as determined by the academic research consortium criteria.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent. Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach. Exclusion Criteria: Individuals < 18 years old. Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site Unsuccessful or abandoned attempt at a secondary arterial access site 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 10^9/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 hemoglobin below 10 g/dL. History of medication noncompliance or risk factor for noncompliance. Active malignancy. Allergy to rivaroxaban. Another indication for anticoagulation. CYP3A4 and P-glycoprotein inhibitor use. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah R Devamani
Phone
(507) 255-0876
Email
Devamani.Sarah@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Simard, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Devamani
Phone
507-255-0876
Email
Devamani.Sarah@mayo.edu
First Name & Middle Initial & Last Name & Degree
Trevor Simard, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs