Blood Thinner for Radial Artery Occlusion
(CAPITAL-RAPTOR Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ottawa Heart Institute Research Corporation
Must not be taking: NSAIDs, CYP3A4 inhibitors
Disqualifiers: Bleeding risk, Liver dysfunction, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if taking a pill after a coronary procedure can prevent artery blockage. It focuses on patients who have the procedure done through their wrist artery. The goal is to see if this pill can help keep the artery open for future use.
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 non-steroidal anti-inflammatory medications or certain other drugs, you may not be eligible to participate.
What data supports the effectiveness of the drug Rivaroxaban for treating radial artery occlusion?
Research shows that Rivaroxaban, when combined with aspirin, reduces major cardiovascular events and mortality in patients with coronary or peripheral artery disease. This suggests that Rivaroxaban may be effective in improving blood flow and reducing complications in similar conditions.
12345Is Rivaroxaban generally safe for humans?
Rivaroxaban has been shown to have a favorable safety profile in terms of bleeding, with a decrease in fatal bleeding compared to other blood thinners, although it may increase the risk of certain events in high-risk patients with specific conditions like antiphospholipid syndrome.
678910How does the drug rivaroxaban differ from other treatments for radial artery occlusion?
Rivaroxaban is unique because it is an oral medication that directly inhibits factor Xa, a key protein in the blood clotting process, which helps prevent arterial thrombosis. Unlike some other blood thinners that require injections or regular blood monitoring, rivaroxaban is taken as a simple daily pill and does not need frequent dose adjustments.
411121314Eligibility 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 with upcoming surgeries, certain heart issues, pregnancy without birth control, bleeding risks, severe liver or kidney disease, recent strokes, allergies to rivaroxaban, or on specific drugs.Inclusion Criteria
I am 18 years old or older.
I have had a heart vessel examination or treatment through my wrist.
Exclusion Criteria
I have had or attempted to have a procedure through another artery or vein.
My heart's rhythm problems don't improve with treatment.
I am scheduled for heart or other surgery within the next 30 days.
I am a woman who can become pregnant and am not using birth control.
I cannot take blood thinners due to a high risk of bleeding.
My liver is not working well.
I need blood thinners for another health condition.
I have been diagnosed with antiphospholipid antibody syndrome.
I have a noticeable bruise or bleeding concern where my wrist was accessed.
I have experienced a severe heart condition that suddenly reduced blood flow.
My kidneys are not working well, with a creatinine clearance under 30mL/min.
My hemoglobin level is below 10 g/dL without a known cause.
I have had a brain bleed in the past.
I currently have cancer.
I have used IIb/IIIa inhibitors during heart artery procedures.
I have had bleeding that needed medical care in the last 6 months.
I am not taking any CYP3A4 or P-glycoprotein inhibitors.
Participant Groups
The study tests if taking Rivaroxaban (a blood thinner) orally once daily for a week after wrist artery access can prevent the artery from closing up. This complication happens in about 5% of cases and prevents future use of this artery.
2Treatment groups
Experimental Treatment
Active Control
Group I: RivaroxabanExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Kingston Health Sciences CenterKingston, Canada
University of Ottawa Heart InstituteOttawa, Canada
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
References
Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. [2021]The combination of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily compared with 100 mg aspirin once daily reduces major adverse cardiovascular (CV) events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
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.
Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. [2019]The cardiovascular outcomes for people using anticoagulation strategies (NCT01776424) trial randomized 27,395 patients with stable coronary artery disease or peripheral artery disease (PAD) to receive rivaroxaban 5 mg twice-daily alone, the combination of rivaroxaban 2.5 mg twice-daily and aspirin 100 mg daily, or aspirin 100 mg daily alone. The combination arm resulted in a 24% reduction in the primary end point of cardiovascular death, stroke or myocardial infarction, and an 18% reduction in mortality. Rivaroxaban alone did not produce any additional benefit compared with aspirin. The combination therapy also reduced major adverse limb events, including amputation, in patients with PAD. Based on these results, the addition of rivaroxaban to aspirin is expected to substantially reduce morbidity and mortality in patients with stable coronary or PAD.
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.
Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. [2022]Rivaroxaban is a selective inhibitor of coagulation factor Xa and its combination with aspirin showed better outcomes in the prevention of recurrent cardiovascular disease than aspirin alone.
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.
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.
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.
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.
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.
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.
Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. [2015]Rivaroxaban (Xarelto) is a novel, oral, direct Factor Xa (FXa) inhibitor in late-stage development for the prevention and treatment of thromboembolic disorders. Rivaroxaban inhibits clot-associated and free FXa activity, and prothrombinase activity, and reduces thrombin generation. In animal models, rivaroxaban prevented venous and arterial thrombosis, and was effective at treating venous thrombosis. Rivaroxaban has high oral bioavailability, a rapid onset of action and predictable pharmacokinetics. In phase II studies, rivaroxaban was effective and well tolerated for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, and for the treatment of deep vein thrombosis. In a phase III study, rivaroxaban demonstrated significantly superior efficacy to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar low bleeding. Rivaroxaban is also being assessed for the treatment and secondary prevention of VTE, prevention of stroke in patients with atrial fibrillation and secondary prevention in patients with acute coronary syndrome. Rivaroxaban is a promising alternative to current pharmacological agents for thromboembolic disorders.
[Rivaroxaban (Xarelto): new anticoagulant inhibitor of factor Xa]. [2015](Xarelto, Bayer Schering Pharma) is a new anticoagulant with a good oral bioavailability, acting as a potent, selective direct inhibitor of factor Xa. It is indicated in the prevention of venous thromboembolism in adult patients after total hip replacement or total knee replacement surgery. In four large clinical trials (RECORD), oral rivaroxaban was more effective than subcutaneous enoxaparin in preventing postoperative venous thromboembolism in patients undergoing such surgery, and this superior efficacy was achieved without significant increase in the incidence of major bleeding episodes. Rivaroxaban offers several advantages as compared with low-molecular-weight heparin preparations and oral coumarinic agents. Its use is easy with only one 10 mg tablet per day and does not require coagulation blood monitoring or dose adjustment. This promising new anticoagulant is currently evaluated in several clinical trials testing other potential indications, among which acute coronary syndrome and atrial fibrillation.
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.