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Trial record 99 of 245 for:    "ottawa heart institute"

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 : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Radial Artery Occlusion Drug: Rivaroxaban 15 MG Oral Tablet [Xarelto] Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1826 participants
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
Official Title: Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]
    Death from any cause as determined by the treating physician

  2. Stroke (ischemic or uncertain) [ Time Frame: 30 days ]
    Stroke (ischemic or uncertain) as defined by a treating neurologist

  3. Stroke (hemorrhagic) [ Time Frame: 30 days ]
    Stroke (hemorrhagic) as defined by a treating neurologist

  4. Fatal bleeding [ Time Frame: 30 days ]
    Bleeding resulting in death as defined by treating physician

  5. 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

  6. Bleeding requiring medical attention [ Time Frame: 30 days ]
    Any bleeding that requires participant to seek medical attention

  7. GUSTO bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

  8. TIMI bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria

  9. BARC bleeding criteria [ Time Frame: 30 days ]
    Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria

  10. Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction as defined by the third universal definition of myocardial infarction.

  11. Stent thrombosis [ Time Frame: 30 days ]
    Stent thrombosis as determined by the academic research consortium criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630055


Contacts
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Contact: Benjamin Hibbert, MD PhD 613-696-7280 bhibbert@ottawaheart.ca
Contact: Pietro Di Santo, MD 613-696-7280 pdisanto@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Benjamin Hibbert, MD PhD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation

Publications:

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03630055     History of Changes
Other Study ID Numbers: 20180319
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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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

Keywords provided by Ottawa Heart Institute Research Corporation:
Direct oral anticoagulants
Transradial access
Percutaneous coronary intervention

Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants