Clinical Trials With Factor Xa Inhibition In The Prevention Of Postoperative Venous Thromboembolism

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Key features of the EXPANSE clinical program for apixaban in

Apixaban is a new oral selective factor Xa inhibitor. Its efficacy and safety are being investigated in a large clinical development program across various indications in venous and arterial thrombotic disorders. A twice-daily regimen was chosen for all the studied indications of apixaban. All three

PRACTICES AND PROTOCOLS IN DVT PROPFIYIAXIS

prophylactic measures for thromboembolism of the lower extremity. Surgeons in this field are presented with common risk factors for venous thromboembolism (VTE) and must deai w-ith the consequences of dosing, monitoring, and addressing complications that arise. i7hile studies exemining this specialty's role in VTE risk and prevention are

Comparison of Post Operative Blood Loss after Total Knee

TKA is 0.3% to 0.4%. Selective factor Xa inhibitors represent a new class of agents. Fondaparinux, a synthetic, selective, indirect factor Xa inhibitor, has been approved for VTE prevention in patients undergoing THA, TKA, and hip fracture surgery based on its efficacy and comparable safety in clinical trials against

Thoracic Epidural Analgesia in the Recently Anticoagulated

-Rivaroxaban (Xarelto) is an oral factor Xa inhibitor indicated for prevention of stroke and venous thromboembolism. It has a half life of 9-13 hours de pending on hepatic and renal

Challenges in the prevention of venous thromboembolism in the

inhibition of factor (F)Xa. In two clinical trials comparing postoperative fondaparinux vs. preoperative enoxaparin for prevention of VTE in patients (mean age > 65 years) under-going elective hip replacement surgery, fondaparinux reduced the risk of VTE by 55.9% ( P<0.0001) and 26.3% (P ¼ 0.099), respectively, compared with enoxaparin [23,24

Advances in the Treatment and Prevention of Venous

with Factor Xa activity directly affects the amount of active thrombin generated and, therefore, the amount of fi brin formed. Preclinical and clinical data support the concept that inhibition of Factor Xa can control thrombogenesis, and this finding has stimulated the development of indirect and direct Factor Xa-inhibiting agents (Table 1).

Influence of Anticoagulant Medication on Fracture-Healing

was approved for the prevention of venous thromboembolism in adult patients undergoing elective hip and knee replacement surgery [24]. The potential effect of anticoagulants on fracture healing was first studied in 1955 by Stinchfield et al., prompted by the observation of high pseudoarthrosis-rates in patients

PRODUCT INFORMATION - GP2U

One unit anti-Xa of FRAGMIN is equivalent in effect to the activity of one unit of the 1st international standard for Low Molecular Weight Heparin with regard to inhibition of coagulation factor Xa in plasma. The 10 000 IU (anti-Xa)/1 mL syringe, 7 500 IU (anti-Xa)/0.75 mL syringe, 5 000 IU

Perioperative Management of Direct Oral Anticoagulants in

vention and treatment of venous thromboembolism (VTE) and for the prevention of cerebrovascular embolism in pa-tients with atrial fibrillation (AF).3 Increasing numbers of elderly patients are presenting for treatment of neurosurgical disorders, such as intracranial tumors and traumatic brain injury (TBI).4,5 This demographic is more likely to be

Dosing Guide - ELIQUIS

In 2 Phase III NVAF clinical trials, approximately 95% of ELIQUIS® (apixaban) patients received this dose. Dosage adjustment Patients with at least 2 of the following: a age ≥80 years b body weight ≤60 kg c serum creatinine ≥1.5 mg/dl 5 mg twice daily 2.5 mg twice daily Please see additional Important Safety Information throughout.

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

prevention of recurrent venous thromboembolism Final scope Remit/appraisal objective To appraise the clinical and cost effectiveness of rivaroxaban within its licensed indication for the treatment of acute symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis and the prevention of recurrent venous thromboembolism.

Anticoagulant Therapy in Pediatrics - jbclinpharm.org

inhibitory effects of AT on thrombin and factor Xa. It is often used for the prevention and treatment of thrombosis in adults and in critically ill children.[12,13] UFH is given to millions of patients annually, and around 15% of inpatients in tertiary pediatric centers.[14,15] The advantages of heparin include many years of clinical

Treatment of Proximal Deep Vein Thrombosis With a Novel

treatments has come from large randomized trials using clinical outcomes.1 3 SR90107a/ORG31540 is a synthetic pentasaccharide4 (Figure 1). It selectively binds to antithrombin and induces a conforma-tional change that increases the anti factor Xa activity of antithrombin 270 times, without inhibition of factor IIa.5 In

Review: Clinical Trial Outcomes INVESTIGATION

Keywords: atrial fibrillation edoxaban factor Xa inhibitor once daily oral anticoagulation venous thromboembolism Venous thromboembolism (VTE) is a serious complication with especially high incidence after major orthopedic surgery, representing an important cause of increased morbidity and mortality [1]. Current guidelines

Postmarketing safety experience with edoxaban in Japan for

Japan for the prevention of venous thromboembolism following major orthopedic surgery. Currently, edoxaban is in Phase III clinical development for the prevention of stroke and systemic embolic events in patients with atrial fibrillation, and for the treatment and prevention of recurrences of venous thromboembolism.

PERSONAL INFORMATION Charles-Marc Samama

Chair of the French Guidelines on Perioperative Venous Thromboembolism (VTE) Prophylaxis (2004 and 2011), Perioperative Use of Antiplatelet Agents (2001 and 2006), and participation as a co-author in the VTE Prophylaxis section of the 8th and 9th Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy (ACCP conference)(2008 and 2012).

Evidence update on the use of oral anticoagulants in clinical

results of clinical trials that demonstrated efficacy and safety that was, at least, non inferior, if not superior, to warfarin and heparins in stroke prevention in atrial fibrillation (AF) and in the treatment and prophylaxis of venous thromboembolism (VTE)2. NOACs used in clinical practice at present include dabigatran, rivaroxaban,

Low-molecular-weight heparin thromboprophylaxis in medical

in a peak plasma factor Xa activity between 0.25 an 0.29 IU/ mL during the first 3 postoperative days and between 0.33 and 0.37 IU/mL from days 4 to 10 [13]. Outside of the ICU setting, meta-analyses of randomized trials have shown the efficacy and safety of UFH thrombo-prophylaxis, and of LMWH thromboprophylaxis, compared

Low molecular weight heparins: are they interchangeable? No

Therapy: An Evaluation of Clinical trials Evidence. New York, Basel: Marcel Dekker, Inc., 1999. 4 Kakkar VV, Murray WJG. Efficacy and safety of low molecular weight heparin (CY216) in preventing postoperative venous thromboembo-lism: a cooperative study. Br J Surg 1985; 72: 786 91. 5 The European Fraxiparine Study (EFS) Group. Comparison of

Review Article - Hindawi

factor Xa inhibitors currently being investigated in clinical trials for the prevention and treatment of VTE in cancer patients. 2.Fondaparinux 2.1. Pharmacodynamic Profile of Indirect Factor Xa Inhibitor. After activation of the coagulation cascade by either the intrinsic or extrinsic pathways, the generation of factor Xa is amplified.

The Novel Oral Anticoagulants - Thieme Connect

cacy and safety data for apixaban, rivaroxaban, and dabigatran in the prevention of venous thromboembolism after major orthopedic surgery Agent (where approved for postoperative VTE prevention) Trial name Dose, frequency Comparator (enoxaparin) VTE a (%) (vs. LMWH %) Relative Risk for VTE (95% CI) Major bleeding (%) (vs. LMWH %)

I would have everie man write what he knowes and no more

required. Phase II and III trials have demonstrated high efficacy compared to low molecular weight heparins in the prevention of venous thromboembolism, and preliminary results in cardiology trials have also shown great promise.24 At present, heparin remains the optimal means of anticoagulation in CPB circuits, but improvements are

Ability of Recombinant Factor VIIa to Reverse the

Background The novel anticoagulant fondaparinux proved to be effective and safe in the postoperative prevention of venous thrombosis. Current phase III trials with this synthetic selective factor Xa inhibitor focus on its use in the treatment of patients with venous and arterial thrombosis.

Treatment of postoperative bleeding after fondaparinux with

for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med 2002;162(16):1833-40. Huvers, et al. Postoperative bleeding after fondaparinux. MAY 2005, VOL. 63, NO. 5 185

Saddle Pulmonary Embolism in a Morbidly Obese Patient on

direct, selective, and reversible inhibition of factor Xa in both the intrinsic and extrinsic coagulation pathways [2]. Xarelto® was first approved in July 2011 for prevention of DVT and PE following knee or hip replacement surgery [3]. The trials that led to the approval of Xarelto ® were the RECORD 1, 2, and 3 trials [3].

REVIEW Should new oral anticoagulants replace low-molecular

of development include several Xa inhibitors (LY-517717, YM150, DU-176b and apixaban [BMS-562247]), a factor IXa inhibitor (TTP889) and an orally active glycosaminoglycan enhancer (odiparcil [SB-424323]), which indirectly enhances thrombin inhibition via heparin cofactor II. This review focuses on the results of trials of dabigatran

AJO DO NOT COPY

bisulfate (Plavix), and aspirin. In some clinical trials in cardiol-ogy, low-dose (82-mg) aspirin has been permitted. In the most recent ACCP guidelines,3 aspirin is included as an acceptable option for thromboembolic prophylaxis after TJAs. It is crucial that patients be stratified by risk for venous thromboembolism

Comparison between New Oral Anticoagulants and Warfarin

prophylaxis/treatment of venous thromboembolism (VTE) and in treatment of acute coronary syndrome (ACS). The NOACs fall into two broad categories: the oral direct factor Xa (FXa) inhibitors (rivaroxaban

NEW ORAL ANTICOAGULANTS FOR VENOUS THROMBOEMBOLISM

stroke prevention in atrial fi brillation, but have since gained approval for treatment or prophylaxis of VTEs. Vitamin K antagonists exert their effects on the coagulation through the inhibition of Factors II, VII, IX, and X. These new oral drugs prevent VTE by targeting Factor Xa or through direct thrombin inhibition (Figure 1).

REFERENCES - SHM Learning Portal

from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014;129(18):1850-1859. 31. Arixtra (fondaparinux) package insert. 2001; www.accessdata.fda.gov. Accessed July 5th, 2018. 32.

Too Thin? Hip Fracture in a Patient on Anticoagulation. A

Rivaroxaban (Xarelto) is an factor Xa inhibitor. Its peak effect is 2.54 hr. With a half life of 5- -9 hr in a healthy person (CrCl>50 ml/min), 5 half-lives would be 2-3 days. In elderly patients the half-life is 9-13 hr making 5 half-lives around 4 days. There is an increased plasma concentration of up to 24% in patients weighing less than 50 kg.

Anticoagulants: Newer Ones, Mechanisms, and Perioperative Updates

Direct factor Xa inhibitors bind directly to the active site of Xa and block its interac-tion with substrates, thereby inhibiting both free and platelet-bound (bound in the pro-throminase complex) factor Xa.5 Rivaroxaban (Xarelto) is the first available oral direct factor Xa inhibitor.

Apixaban and oral implications

Apixaban is an orally active, direct selective factor Xa inhibitor. It reversibly and selectively inhibits the activa-tion site of factor Xa (4,5), a trypsin-like serine protease which is the final enzyme in the coagulation cascade, being responsible for fibrin clot formation. Factor Xa serves as the link between the extrinsic and intrinsic

Thoracic Epidural and Regional Analgesia in the Patient on a

-Rivaroxaban (Xarelto) is an oral non-AT-III dependent factor Xa inhibitor indicated for prevention of stroke and venous thromboembolism. It has a half life of 913 hours depending on hepatic and renal - clearance. Based on European guidelines, it should be held 2226 hours prior to intervention and -

Melagatran for thromboprophylaxis after mechanical valve

anti-Xa activity level (with the factor Xa inhibition test) to 0.6 to 1.0 IU/mL for the LMWH (dalteparin) group.8 Anticoagulant administration was begun the morning of the first postoperative day and continued for 30 days. The melagatran group (n 6) received 2.4 mg/kg melagatran subcutaneously every 8 hours; the

Therapeutic monitoring of direct oral anticoagulants an 8

Clinical trials have confirmed the efficacy and safety in typical populations of patients with atrial fibrillation, deep vein thrombosis, pulmonary embolism [7 10]. Randomized clinical trials have shown a reduced risk (32 69%) of major bleeding for dabigatran, rivaroxaban and apixaban compared to VKA [11]. Compared to warfarin, DOACs reduce the

Chapter 3

factor VIIa and activated prothrombin complex concentrate may reverse the effects of high-dose rivaroxaban [3 5]. The clinical development programs for rivaroxaban are outlined in Table 3.1 [6 23]. 3.1.1 Venous Thromboembolism Prevention following Joint Surgery Four completed phase II efficacy and safety studies of rivar-

Pulmonary embolism four days after interruption of therapy

Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study, a multicenter, randomized, double-blind trial with the participation of 14,264 patients (1). After the ROCKET AF study, an end of study (EOS) visit was performed and the partici-