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

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ClinicalTrials.gov Identifier: NCT03630055
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE October 3, 2018
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • All cause mortality [ Time Frame: 30 days ]
    Death from any cause as determined by the treating physician
  • Stroke (ischemic or uncertain) [ Time Frame: 30 days ]
    Stroke (ischemic or uncertain) as defined by a treating neurologist
  • Stroke (hemorrhagic) [ Time Frame: 30 days ]
    Stroke (hemorrhagic) as defined by a treating neurologist
  • Fatal bleeding [ Time Frame: 30 days ]
    Bleeding resulting in death as defined by treating physician
  • 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
  • Bleeding requiring medical attention [ Time Frame: 30 days ]
    Any bleeding that requires participant to seek medical attention
  • GUSTO bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
  • TIMI bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
  • BARC bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
  • Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction as defined by the third universal definition of myocardial infarction.
  • Stent thrombosis [ Time Frame: 30 days ]
    Stent thrombosis as determined by the academic research consortium criteria.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
Official Title  ICMJE Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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)
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Radial Artery Occlusion
Intervention  ICMJE Drug: Rivaroxaban 15 MG Oral Tablet [Xarelto]
Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.
Other Name: Xarelto
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rivaroxaban 15 MG Oral Tablet [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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2020)
1800
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
1826
Estimated Study Completion Date  ICMJE August 30, 2022
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Benjamin Hibbert, MD PhD 613-696-7280 bhibbert@ottawaheart.ca
Contact: Pietro Di Santo, MD 613-696-7280 pdisanto@ottawaheart.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630055
Other Study ID Numbers  ICMJE 20180319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ottawa Heart Institute Research Corporation
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP