Rivaroxaban for Radial Artery Occlusion
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Mayo Clinic
Must not be taking: NSAIDs, Glycoprotein IIb/IIIa inhibitors
Disqualifiers: Pregnancy, Liver dysfunction, Active malignancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using certain medications like strong CYP3A4 and P-glycoprotein inhibitors, or regular non-steroidal anti-inflammatory drugs (except low-dose Aspirin), you may not be eligible to participate.
What data supports the effectiveness of the drug Rivaroxaban for preventing radial artery occlusion?
Research shows that using Rivaroxaban for a short time after coronary procedures can help prevent radial artery occlusion, which is a common complication when accessing the heart through the wrist.
12345Is Rivaroxaban generally safe for humans?
Rivaroxaban is generally considered safe for humans, with studies showing it has a favorable safety profile, particularly with a lower risk of fatal bleeding compared to some other blood thinners. However, in high-risk patients with antiphospholipid syndrome, it was associated with more adverse events compared to warfarin.
16789How does the drug rivaroxaban differ from other treatments for radial artery occlusion?
Rivaroxaban is unique because it is an oral anticoagulant that directly inhibits Factor Xa, a key protein in the blood clotting process, which helps prevent blood clots more effectively than some traditional treatments. Unlike other anticoagulants that may require injections, rivaroxaban is taken orally, making it more convenient for patients.
1011121314Eligibility Criteria
This trial is for adults who've had a coronary angiography or heart intervention via the wrist artery and can consent to participate. It's not for those under 18, with bleeding risks, liver dysfunction, severe anemia, noncompliance history, active cancer, allergy to rivaroxaban, other anticoagulant needs, certain drug use, expected short lifespan, pregnant women not using birth control or with severe kidney disease.Inclusion Criteria
I have had a heart vessel examination or treatment through my wrist.
Willing and able to provide written informed consent.
Exclusion Criteria
My hemoglobin is below 10 g/dL and the cause is unknown.
I am a woman who can become pregnant and am not using birth control.
My liver is not working well.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive rivaroxaban 15mg tablet orally once daily for 7 days following transradial access
1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of radial artery occlusion and bleeding events
30 days
Participant Groups
The CAPITAL-RAPTOR trial is testing if taking rivaroxaban for one week after wrist artery access during heart procedures can prevent the artery from getting blocked later on. The effect will be checked by ultrasound at 30 days post-procedure.
2Treatment groups
Experimental Treatment
Active Control
Group I: Rivaroxaban GroupExperimental Treatment1 Intervention
Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.
Group II: Standard of Care GroupActive Control1 Intervention
Subjects will receive the usual standard of care following transradial access.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
Ottawa Heart Institute Research CorporationCollaborator
References
Prevention of radial artery occlusion with rivaroxaban after trans-radial access coronary procedures: The RIVARAD multicentric randomized trial. [2023]Radial artery occlusion (RAO) remains the most frequent complication of trans-radial access. Once the radial artery is occluded, its future use as an access site for coronary procedures, or as a conduit for coronary bypass grafting or fistula for hemodialysis, will be precluded. Therefore, we aimed to assess the value of the short-term use of Rivaroxaban to prevent RAO after a trans-radial coronary procedure.
Treatment of radial artery occlusions using balloon angioplasty and localized intra-arterial abciximab. [2018]To study an alternative strategy for the treatment of radial artery occlusion (RAO) using balloon angioplasty and intrathrombus administration of abciximab.
Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial. [2022]Adequate procedural anticoagulation is crucial for radial artery occlusion (RAO) prevention in patients undergoing transradial access coronary catheterization, although the effect of postprocedural anticoagulation lack thorough investigation. The aim of this study was to evaluate the clinical value of short-term postoperative anticoagulation with rivaroxaban for 24 hours and 1-month RAO prevention in patients who received transradial coronary procedures.
Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial. [2021]Radial artery occlusion (RAO) is the most common complication following transradial approach (TRA) for cardiac catheterisation. Our aim was to assess if decreasing radial hemostatic device (RHD) time reduces the risk of RAO among individuals receiving small sheath sizes with no adjunctive heparin.
Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis. [2018]Incidence of radial artery occclusions (RAO) and ulnar artery occclusions (UAO) in coronary procedures, factors predisposing to forearm arteries occlusion, and the benefit of anticoaggulation vary significantly in existing literature. We sought to determine the incidence of RAO/UAO and the impact of anticoagulation intensity.
Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure. [2023]Trial of Rivaroxaban in AntiPhospholipid Syndrome was a prospective randomized, open-label, noninferiority study conducted in 14 centers in Italy. Rivaroxaban was compared with warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk, triple-positive patients with antiphospholipid syndrome.
Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. [2021]Rivaroxaban is an effective and safe alternative to warfarin in patients with atrial fibrillation and venous thromboembolism. We tested the efficacy and safety of rivaroxaban compared with warfarin in high-risk patients with thrombotic antiphospholipid syndrome. This is a randomized open-label multicenter noninferiority study with blinded end point adjudication. Rivaroxaban, 20 mg once daily (15 mg once daily based on kidney function) was compared with warfarin (international normalized ratio target 2.5) for the prevention of thromboembolic events, major bleeding, and vascular death in patients with antiphospholipid syndrome. Only high-risk patients triple positive for lupus anticoagulant, anti-cardiolipin, and anti-β2-glycoprotein I antibodies of the same isotype (triple positivity) were included in the study. The trial was terminated prematurely after the enrollment of 120 patients (59 randomized to rivaroxaban and 61 to warfarin) because of an excess of events among patients in the rivaroxaban arm. Mean follow-up was 569 days. There were 11 (19%) events in the rivaroxaban group, and 2 (3%) events in the warfarin group. Thromboembolic events occurred in 7 (12%) patients randomized to rivaroxaban (4 ischemic stroke and 3 myocardial infarction), whereas no event was recorded in those randomized to warfarin. Major bleeding occurred in 6 patients: 4 (7%) in the rivaroxaban group and 2 (3%) in the warfarin group. No death was reported. The use of rivaroxaban in high-risk patients with antiphospholipid syndrome was associated with an increased rate of events compared with warfarin, thus showing no benefit and excess risk. This trial was registered at www.clinicaltrials.gov as #NCT02157272.
[Rivaroxaban at Non-Valvular Atrial Fibrillation: a Prospective Study and Clinical Practice]. [2019]The article presents an analytical review of the results of post-registration clinical studies on the efficacy and safety of rivaroxaban in nonvalvular atrial fibrillation (AF) to prevent stroke and other systemic thromboembolic complications. The main purpose of the first large prospective international observational study of rivaroxaban for stroke prevention in patients with non-valvular AF patients XANTUS was the analysis of efficacy and safety of rivaroxaban in clinical practice. Results of one year of observation of 6784 patients confirmed that rivaroxaban is effective and safe in real unselected population of patients with non-valvular AF and various stroke risk. The first Russian multicenter observational study Neuro-Xar dedicated to secondary prevention of stroke and systemic embolism, demonstrated the efficacy and safety of rivaroxaban in routine clinical practice. Lower risk of fatal intracranial and gastrointestinal bleeding was found in retrospective post-marketing studies, of rivaroxaban in the US, such as the PMSS and REVISIT-US. Rivaroxaban therapy was associated with reduced risk of the combined endpoint (ischemic stroke and intracranial hemorrhage).
Meta-analysis of rivaroxaban and bleeding risk. [2015]Rivaroxaban, a factor Xa inhibitor, is a new oral anticoagulant that has been developed as an alternative to vitamin K antagonists. However, its safety remains unclear. Reported randomized controlled trials comparing the safety of rivaroxaban with that of vitamin K antagonists (warfarin, acenocoumarol, phenprocoumon, and fluindione) were systematically searched. Inclusion was restricted to studies of ≥30 days' treatment duration. Safety end points examined included major and clinically relevant nonmajor bleeding, as well as mortality. Data were pooled across randomized controlled trials using random-effects meta-analysis models. Five randomized controlled trials including 23,063 patients that met the inclusion criteria were identified. Patients received treatment for nonvalvular atrial fibrillation (n = 14,264), deep vein thrombosis (n = 3,967), or acute symptomatic pulmonary embolism (n = 4,832). Overall, rivaroxaban was not associated with the risk of a composite end point of major or clinically relevant nonmajor bleeding (relative risk 0.99, 95% confidence interval 0.93 to 1.06). However, rivaroxaban was associated with a significant decrease in fatal bleeding (relative risk 0.48, 95% confidence interval 0.31 to 0.74). In 2 studies reporting intracranial bleeding events, rivaroxaban was associated with decreased risk compared with vitamin K antagonists. It was not associated with decreased risk for all-cause mortality (relative risk 0.89, 95% confidence interval 0.73 to 1.09). In conclusion, with a decrease in fatal bleeding and no suggestion of an increase in all-cause mortality, rivaroxaban has a favorable safety profile with respect to bleeding.
The Rivaroxaban Program and the Management of Unmet Needs in Thromboembolic Disease. [2019]Rivaroxaban is a non-vitamin K antagonist oral anticoagulant that acts as a direct factor Xa inhibitor, and is widely used for the prevention and treatment of thromboembolic disorders. As further knowledge gaps are identified in thrombosis management, the rivaroxaban research program has expanded in an attempt to elucidate the wider benefits of rivaroxaban. An increased understanding of the interactions taking place within the coagulation cascade may support a broader role for rivaroxaban (2.5 mg twice daily [bid] or 5 mg bid) in the setting of vascular protection, either alone or in combination with an antiplatelet agent. The aim of this article is to describe the potential role of rivaroxaban in the context of vascular protection and provide an overview of recently completed and ongoing randomized controlled trials of rivaroxaban in the areas of stroke prevention, venous protection and vascular protection.
Combination of Superficial and Deep Blocks with Rivaroxaban. [2015]Rivaroxaban is a new Xa inhibitor indicated for thromboprophylaxis in patients undergoing joint arthroplasty. This study was designed to assess the risk of major bleeding from the combination of either a single or a continuous deep, superficial, and plexus block and the use of rivaroxaban for thromboprophylaxis following joint arthroplasty.
Rivaroxaban: a review of its use in acute coronary syndromes. [2021]Rivaroxaban (Xarelto(®)) is an orally administered highly selective direct inhibitor of factor Xa that has been approved in many countries to reduce the risk of stroke in patients with atrial fibrillation and for the treatment and prevention of venous thromboembolism. More recently, rivaroxaban at a low dosage of 2.5 mg twice daily, co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine, was approved for use in the EU for patients with a recent acute coronary syndrome (ACS). The approval of rivaroxaban in ACS was primarily based on findings of the phase III ATLAS ACS 2-TIMI 51 trial, which showed that after a median of 13.1 months of treatment with rivaroxaban 2.5 mg twice daily (combined with aspirin or aspirin plus either clopidogrel or ticlopidine) there was a statistically significant reduction in the rate of the primary composite endpoint, which was death from cardiovascular causes, myocardial infarction or stroke, compared with placebo. Rivaroxaban 2.5 mg twice daily was also associated with a reduction in all-cause and cardiovascular mortality. There was an increase in the risk of major bleeding and intracranial haemorrhage with rivaroxaban 2.5 mg twice daily compared with placebo; however, there was no increase in the risk of fatal bleeding. Aspirin plus either ticagrelor or prasugrel was not evaluated as background dual antiplatelet therapy in ATLAS ACS 2-TIMI 51 and the safety implications of rivaroxaban used in combination with such therapy are unknown. In conclusion, results of the ATLAS ACS 2-TIMI 51 trial suggest a potentially important role for rivaroxaban 2.5 mg twice daily co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine in patients with a recent ACS.
Spontaneous rectus sheath hematoma during rivaroxaban therapy. [2021]Rivaroxaban is an oral anticoagulant agent that directly inhibits Factor Xa and interrupts both the intrinsic and extrinsic pathway of the coagulation cascade and is currently indicated for use in patients for atrial fibrillation and prophylaxis of deep venous thrombosis. The present case reports of spontaneous rectus sheath hematoma during rivaroxaban therapy for atrial fibrillation in a 75-year-old woman.
Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis. [2022]Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved in several countries for thromboprophylaxis after elective hip or knee arthroplasty based on favorable benefit-risk profile and improved efficacy compared to enoxaparin in reducing the composite of symptomatic and asymptomatic deep vein thrombosis, nonfatal pulmonary embolism, and all-cause mortality. Given the potential therapeutic utility of factor Xa inhibition in arterial thrombosis, we evaluated the antithrombotic activity of rivaroxaban in a model of arterial thrombosis in anesthetized rats in which thrombotic occlusion was induced by electrolytic injury of the carotid artery. Rivaroxaban, 0.3, 1 or 3 mg/kg, enoxaparin, 10 mg/kg, or vehicle were infused intravenously to anesthetized rats and time to occlusion as well as coagulation parameters monitored following carotid electrolytic injury. Although the lowest dose of rivaroxaban (0.3 mg/kg) did not prolong occlusion time compared to vehicle, rivaroxaban at 1 or 3 mg/kg prevented occlusion in all vessels during the 30-min observation period (median occlusion time >30 min), which was greater than that following a single dose of enoxaparin infused at a dose of 10 mg/kg (median time to occlusion = 21.6 min). Rivaroxaban was also effective following oral dosing at 3 mg/kg. Rivaroxaban's antithrombotic activity was paralleled by dose-dependent increases in prothrombin time (PT) and activated clotting time (ACT) without significant changes in activated partial thromboplastin time. Rivaroxaban also markedly increased Russell's viper venom time (RVVT) and decreased thrombin-antithrombin complex concentrations at all doses. These findings support the potential utility of rivaroxaban in arterial thrombotic disorders such as acute coronary syndrome, stroke and peripheral arterial disease.