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Apixaban

Apixaban is a direct factor Xa inhibitor used as an anticoagulant for the prevention and treatment of various thromboembolic disorders, such as deep vein thrombosis and pulmonary embolism.
It works by blocking the activity of factor Xa, a key enzyme in the blood clotting cascade.
Apixaban has been shown to be effective in reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and in reducing the risk of recurrent venous thromboembolism.
It is available in oral tablet form and is typically taken twice daily.
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Most cited protocols related to «Apixaban»

To demonstrate the utility of standardizing disparate data sources into a CDM, we replicated a published observational study protocol and evaluated the quality of a standardized approach and time-to-execution. As an exemplar, we used the Mini-Sentinel analysis of the comparative effectiveness of rivaroxaban versus warfarin on various outcomes in patients with atrial fibrillation.30 We developed a standardized analytic routine that replicated the cohort definitions within the protocol and applied the analytic program across all 6 databases to compare the impact of the inclusion criteria on the proportion of patients qualifying for the study.
Specifically, we identified all new users of each target drug (warfarin and rivaroxaban) who satisfied the following 7 criteria of the original study: (1) had at least 183 days of nonexposure before the first target drug exposure; (2) had at least 1 atrial fibrillation or atrial flutter diagnosis code within the 183-day window prior to first exposure; (3) did not have any prior diagnosis or procedure codes indicative of long-term dialysis; (4) did not have any prior diagnosis or procedure codes indicative of kidney transplant; (5) did not have any prior diagnosis or procedure code indicative of mitral stenosis or mechanical heart valve; (6) did not have any prior procedure code indicative of joint replacement or arthroplasty surgery; and (7) did not have prior use of any anticoagulant (warfarin, rivaroxaban, dabigatran, or apixaban). For each target drug, we created 2 cohorts: new users of the drug (defined by satisfying criteria No. 1), and the subset of those new users of the drug who satisfied the remaining 6 criteria. For each cohort, we produced a standardized descriptive summary of the population, including demographics (gender and age distribution), comorbidities (prevalence of conditions in time window prior to cohort entry), concomitant medications (prevalence of drug exposure in time window prior to cohort entry), and service utilization (prevalence of procedures in time window prior to cohort entry). We measured the execution time for the standardized analytic routine when applied to each target drug across all 6 databases. Analyses were conducted on a Microsoft Server 2008 (Microsoft Corporation, Redmond, Washington) with an AMD Opteron 6172 (Advanced Micro Devices, Inc, Sunnyvale, California), 2.10 GHz, 2 processors, 24-core CPU, and 256 GB of RAM. Each CDM was stored in a separate database within an instance of Microsoft SQL Server 2012 (Microsoft Corporation, Redmond, Washington).
Appendix 1 contains the standard concepts and corresponding source codes that were used to define each of the core concepts required within the prespecified protocol.
Publication 2015
Anticoagulants apixaban Arthroplasty Arthroplasty, Replacement Atrial Fibrillation Atrial Flutter Dabigatran Diagnosis Dialysis Drug Abuser Drug Delivery Systems Heart, Artificial Heart Valves Kidney Transplantation Medical Devices Mitral Valve Stenosis Operative Surgical Procedures Patients Pharmaceutical Preparations Rivaroxaban Warfarin
Patients were enrolled at 63 centers in North America and Europe. Patients were eligible if they were at least 18 years of age, presented with acute major bleeding, and had received within 18 hours one of the following: apixaban, rivaroxaban, or edoxaban at any dose or enoxaparin at a dose of at least 1 mg per kilogram of body weight per day. Acute major bleeding was defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise (e.g., severe hypotension, poor skin perfusion, mental confusion, or low cardiac output that could not otherwise be explained); bleeding associated with a decrease in the hemoglobin level of at least 2 g per deciliter (or a hemoglobin level of ≤8 g per deciliter if no baseline hemoglobin level was available); or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome). Written informed consent was obtained from all the patients, whether directly from the patient, by proxy consent from a legally authorized representative, or by emergency consent (as described in the Supplementary Appendix, available at NEJM.org).
Patients were enrolled from April 2015 through May 2018. From July 2016 through August 2017, only patients with intracranial hemorrhage were enrolled to enrich the study with these patients. After August 2017, patients with all types of bleeding except visible, musculoskeletal, or intraarticular bleeding were enrolled. Substantive amendments to the enrollment criteria during the trial are presented in the Supplementary Appendix.
Key exclusion criteria were planned surgery within 12 hours after andexanet treatment (with the exception of minimally invasive operations or procedures); intracranial hemorrhage in a patient with a score of less than 7 on the Glasgow Coma Scale (scores range from 15 [normal] to 3 [deep coma]) or an estimated hematoma volume of more than 60 cc; expected survival of less than 1 month; the occurrence of a thrombotic event within 2 weeks before enrollment; or use of any of the following agents within the previous 7 days: vitamin K antagonist, dabigatran, prothrombin complex concentrate, recombinant factor VIIa, whole blood, or plasma.
Publication 2019
andexanet apixaban BLOOD Body Weight Comatose Compartment Syndromes Dabigatran edoxaban Emergencies Enoxaparin Factor IX Complex Hematoma Hemodynamics Hemoglobin Hemoglobin A Intracranial Hemorrhage Minimally Invasive Surgical Procedures Operative Surgical Procedures Patients Perfusion Pericardium Plasma recombinant FVIIa Retroperitoneal Space Rivaroxaban Skin Vitamin K
A Markov cohort model was developed, in accordance with good modelling practices,10 (link) conceptualizing the course of the disease in terms of mutually exclusive health ‘states’ and the possible transitions among them, accruing direct healthcare costs, life years, and quality-adjusted life years (QALYs) (Figure 1). The health states considered were NVAF (i.e. the starting health state for all patients), ischaemic or unspecified strokes (referred hereafter as ischaemic stroke), systemic embolism, myocardial infarction (MI), intracranial haemorrhage, other major bleed, clinically relevant non-major bleed, cardiovascular hospitalization unrelated to the events modelled or death. A detailed description of the model can be found in Supplementary material online, Appendix SC.

Schematic representation model. ASA, aspirin CRNM, clinically relevant non-major; ICH, intracranial haemorrhages; NVAF, non-valvular atrial fibrillation; AC, anticoagulant; IS, ischaemic stroke; HS, haemorrhagic stroke. ‘M’ represents a Markov process with 11 health states that are identical for each of the treatment options. All patients remain in the ‘NVAF’ state until one of stroke, bleed, SE, MI, treatment discontinuation, or death occurs. The transition probabilities of these events depend on the treatment. For patients on second-line aspirin ‘NVAF subsequent ASA’ the events are identical however patients cannot experience any further discontinuation. Triangles indicate which health state the patient enters after an event. Health states coloured in blue are permanent health states, with the remainder being transient health states occurring for a maximum period of 6 weeks before returning to the prior or subsequent health state.

Publication 2014
Anticoagulants Atrial Fibrillation Cardiovascular System Cerebrovascular Accident Disease Progression Embolism Hemorrhagic Stroke Hospitalization Intracranial Hemorrhage Myocardial Infarction Patients Stroke, Ischemic Transients
Patients who meet all preliminary inclusion and exclusion criteria and provide consent then undergo screening for atrial cardiopathy, defined as ≥1 of the following:
The thresholds for each of these biomarkers were chosen based on their associations with increased risk of stroke or stroke recurrence from observational studies. Each was associated with approximately a doubling of risk of stroke in these studies. Although the precise levels of each biomarker that should be used to determine the presence of atrial cardiopathy remains a matter of study, our use of a broad range of biomarkers and the requirement that only one criterion be met were chosen to facilitate testing of our second hypothesis that atrial cardiopathy represents a spectrum of illness, with different levels of severity.
The left atrial diameter index is determined by the local echocardiography laboratory at each site. PTFV1 is centrally determined at the ARCADIA ECG Core. Serum NT-proBNP is centrally assayed from blood samples sent to the ARCADIA Laboratory Core. Patients who fulfill any one of the atrial cardiopathy criteria are randomized in a 1:1 ratio to apixaban or aspirin using a web-based central randomization system and a randomization method that controls the maximum tolerated imbalance within each NIH StrokeNet Regional Coordinating Center.30 (link)Randomization can occur as early as post-stroke day 3, but must be delayed until at least post-stroke day 14 for participants with severe strokes (initial NIH Stroke Scale [NIHSS] score ≥11), hemorrhagic transformation of the index stroke, or uncontrolled hypertension. For all strokes, randomization must occur no later than post-stroke day 120.
Publication 2018
apixaban Aspirin Atrium, Left Biological Markers BLOOD Cerebrovascular Accident Echocardiography Heart Atrium Heart Diseases Hemorrhagic Stroke High Blood Pressures Patients pro-brain natriuretic peptide (1-76) Recurrence Serum
A systematic review of RWE studies enrolling patients with NVAF was the basis for this meta-analysis. The methodology of the review adhered to the guidance from the Centre for Reviews and Dissemination (CRD) from the University of York [10] and the Cochrane Handbook for Systematic Reviews of Interventions [11]. Detailed results of the SLR were published separately [12].
The population of interest was adults (aged ≥18 years) with NVAF receiving an oral anticoagulant. Both studies reporting on incident (i.e., beginning anticoagulant treatment) and prevalent (i.e., continuing treatment) patients were included. The interventions of interest were the Factor Xa inhibitors apixaban and rivaroxaban and the direct thrombin inhibitor dabigatran.
The following databases were searched on 1 December 2016: Medline and Embase (accessed using the Ovid platform), and the Cochrane Library (accessed via Wiley Interscience), including the Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE), the Cochrane Central Register of Controlled Trials (CENTRAL), the Health Technology Assessment (HTA) database, and the NHS Economic Evaluation Database (NHS EED). No restrictions were applied in terms of publication date, language, or geographical scope. Details of the search strategy are presented in the Supplementary Material.
Two independent reviewers performed the study selection, and any differences were resolved by a third reviewer. Extracted data were those on citation characteristics, study details, patient characteristics, results, and study limitations; all extracted data were quality-checked by a second reviewer.
The outcomes of interest relating to drug efficacy were: IS, all-cause mortality, myocardial infarction (MI), venous thromboembolism (VTE), a composite of ischemic stroke or systemic embolism (IS/SE), and a composite of IS/SE/all-cause mortality. Outcomes of interest relating to drug safety were: HS, ICH, major bleeding, gastrointestinal (GI) bleeding, and any bleeding. A final outcome of interest was persistence/non-persistence, defined as a break in treatment of at least 60 days.
The following three comparisons were made: 1) rivaroxaban vs. VKAs, 2) dabigatran vs. VKAs, and 3) apixaban vs. VKAs using the inverse variance-weighted method to pool hazard ratios (HRs) and their 95% confidence intervals (CIs) in a meta-analysis. The inverse variance-weighted method was used based on a common assumption that the ln(HR) followed a normal distribution. The analysis was conducted on HRs to take into account adjustments on baseline characteristics made in each study. In line with previously published methodology [13], when no HR was available the incidence rate ratio was used instead. If there were no events in one arm of a study, a continuity correction was applied, while studies with no events in either treatment arm were excluded from the analyses [11]. Details of input calculations are provided in the Supplementary Material.
If results at different follow-up times were available in a study, the longest follow-up was used. Additionally, if more than one study used the same database, only the study with the highest level of precision was used (i.e., only the study for which the standard error of the log of HR was the smallest was included). For example, 21 studies assessing dabigatran vs. VKAs based on the MarketScan® database were identified. Inclusion of studies using the same database and investigating similar outcomes could lead to the same patients being repeatedly included in the analysis, which could bias the results. Analyses did not account for different doses (i.e., data for 15 mg and 20 mg rivaroxaban doses, and 110 mg and 150 mg dabigatran doses were pooled together).
Heterogeneity between studies was assessed using the p-value of the Cochrane Q test and the I-squared, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions [11]. Both the fixed- and random-effects models were fitted. Given the heterogeneity between study designs, results of the random-effects model are presented. Analyses were conducted using SAS 9.3®. Meta-analysis results are presented in the text as the number of studies included in the comparison (n), and HR with its [95% CI], unless otherwise indicated.
Publication 2019

Most recents protocols related to «Apixaban»

Apixaban tablets (2.5 mg) were obtained from Zhejiang Yongning Pharmaceutical Co., Ltd. (test formulation) and Bristol‐Myers Squibb Company (Eliquis, reference formulation).
Publication 2024
Based on the chemical structure of apixaban, we used the ADMET prediction module in GastroPlus to predict physicochemical and biopharmaceutical parameters. The model was constructed using the following critical compound attributes: molecular weight, log P, pKa, fraction unbound in plasma (Fup), Blood‐to‐plasma ratio, intestinal effective permeability (Peff), and solubility of reference formulation.
Publication 2024
The first round of designs used the RosettaDesign protocol (without fixed backbone) where all residues within 10 Å of apixaban, but excluding the catalytic triad necessary for FXa activity, were designated as the “cavity”. The top-scoring delta “total_score” and delta “cavity_score” mutations were identified, and their sequence profiles were analyzed. The mutations identified through RosettaDesign were threaded with the FastRelax protocol onto the structure of the FXa-apixaban complex (see Supplementary Information) to construct final models. Through manual inspection of the FXa variants, we either retained the mutation or reverted to the wild-type amino acid based on conventional structural biology principles. The resulting 21 designs were experimentally validated. Building on the experimental results from first round of design a second round of design was initiated. This round focused on creating conservative single- and double-point mutations that could hinder apixaban binding but retain functional activity. This second round of design resulted in 9 designs for further experimental validation. All script files used for design are provided in Supplementary Information as “Computational scripts and files” and files are provided in “zip file”.
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Publication 2024
Patients were eligible for recruitment if they were ≥ 18 years old, had received apixaban for at least 7 days, diagnosed with NVAF, and provided written informed consent. Patients were excluded if they denied providing informed consents, had moderate to severe mitral valve stenosis, mechanical valve replacement, Child–Pugh class C, chronic liver disease, or end-stage renal disease with or without dialysis or kidney transplantation, pregnant or breastfeeding, unable to perform self-care without a caregiver, or incompatible to receive apixaban and concomitantly using strong CYP3A4 and P-gp inhibitors. All patients who were included, were already receiving apixaban with or without amiodarone before enrollment based on the actual use of amiodarone before inclusion. The adherence to the use of these medications within 7 days before enrollment were determined by telephone and pill count method. After that patients were categorized into two groups as follows: apixaban monotherapy (control group) and apixaban with amiodarone groups. In addition, all patients received an appropriate apixaban dose based on clinical practice guidelines: the standard dose of apixaban is 5 mg twice daily. When patients have at least 2 of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine (SCr) ≥ 1.5 mg/dL the recommended dose of apixaban is 2.5 twice daily [14 (link)].
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Publication 2024
Demographic data including age, gender, body weight, SCr, creatinine clearance (CrCl) by Cockcroft-Gault equation, comorbidities, relevant information about their AF (CHA2DS2VASc, and HAS-BLED score) were extracted from the hospital database. In addition, specific information about apixaban and amiodarone therapy including doses and duration of usage were obtained.
Two blood samples were collected for apixaban level measures at steady state; 1) at recruitment taken before taking their morning dose of apixaban in the morning, 2) the peak level was taken after taking apixaban within 2–4 hours. After that, blood samples were collected into two 3.2% citrated tubes to measure both the trough and peak concentrations. The blood samples were centrifuged immediately for 15 mins at 2500–3000×g [14 (link)–16 (link), 21 (link)]. Apixaban plasma levels were measured by chromogenic assay, which were performed with the BIOPHENTM heparin LRT kit (Hyphen BioMed, Neuville-sur-Oise, France) and analyzed by a Sysmex CS 2500 System (Siemens Health Care, Milan, Italy). This assay was calibrated with commercial apixaban (sensitivity range 0–600 ng/mL) and calibrated with LMWH (Low Molecular Weight Heparin) sensitivity range about 0–1.75 international units per milliliter (IU/mL). Apixaban levels were compared to the expected ranges of 69–321 ng/mL and 34–230 ng/mL for the peak and trough levels, respectively [14 (link)]. The anti-Xa levels were measured by the same method as the apixaban levels, using indirect method to standardize in the LMWH scale. All reagents and instruments were used in accordance with the manufacturers’ instructions.
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Publication 2024

Top products related to «Apixaban»

Sourced in United States
Apixaban is a laboratory product manufactured by Selleck Chemicals for research purposes. It is a direct and selective inhibitor of factor Xa, a key component in the blood coagulation cascade. The core function of Apixaban is to inhibit the activity of factor Xa, which plays a crucial role in the formation of blood clots.
Sourced in France
The STA®-Liquid Anti-Xa is a laboratory equipment product manufactured by Diagnostica Stago. It is used for the quantitative determination of heparin (unfractionated and low molecular weight) and fondaparinux in plasma samples.
Sourced in United States, Austria, Japan, Cameroon, Germany, United Kingdom, Canada, Belgium, Israel, Denmark, Australia, New Caledonia, France, Argentina, Sweden, Ireland, India
SAS version 9.4 is a statistical software package. It provides tools for data management, analysis, and reporting. The software is designed to help users extract insights from data and make informed decisions.
Sourced in Canada
Apixaban is a laboratory equipment product used for the detection and measurement of apixaban, a direct oral anticoagulant drug. The product is designed to provide accurate and reliable results for clinical or research applications involving apixaban analysis.
Sourced in Canada, United States
Rivaroxaban is a laboratory-grade product designed for research and analytical purposes. It is a direct factor Xa inhibitor used to measure and analyze blood coagulation and related parameters in various research and diagnostic applications.
Sourced in United States, Austria, Japan, Belgium, United Kingdom, Cameroon, China, Denmark, Canada, Israel, New Caledonia, Germany, Poland, India, France, Ireland, Australia
SAS 9.4 is an integrated software suite for advanced analytics, data management, and business intelligence. It provides a comprehensive platform for data analysis, modeling, and reporting. SAS 9.4 offers a wide range of capabilities, including data manipulation, statistical analysis, predictive modeling, and visual data exploration.
Sourced in Germany, United States, Spain
HemosIL is a laboratory equipment product offered by Werfen. It is designed for the analysis of hemostasis parameters. The core function of HemosIL is to perform coagulation and thrombosis testing to assess the clotting ability of blood samples.
Sourced in United States, Japan, Austria, Germany, United Kingdom, France, Cameroon, Denmark, Israel, Sweden, Belgium, Italy, China, New Zealand, India, Brazil, Canada
SAS software is a comprehensive analytical platform designed for data management, statistical analysis, and business intelligence. It provides a suite of tools and applications for collecting, processing, analyzing, and visualizing data from various sources. SAS software is widely used across industries for its robust data handling capabilities, advanced statistical modeling, and reporting functionalities.
Sourced in France
The STA-ECA II is a laboratory equipment product manufactured by Diagnostica Stago. It is designed to perform coagulation and hemostasis testing. The core function of the STA-ECA II is to analyze blood samples and provide objective data on the patient's coagulation profile.
Sourced in United States, Italy
Recombiplastin is a laboratory reagent used in coagulation assays. It contains recombinant human tissue factor and synthetic phospholipids, which are necessary for the activation of the extrinsic pathway of the coagulation cascade.

More about "Apixaban"

Apixaban is a direct factor Xa inhibitor used as an anticoagulant medication for the prevention and treatment of various thromboembolic (blood clot) disorders, such as deep vein thrombosis (DVT) and pulmonary embolism (PE).
It works by blocking the activity of factor Xa, a crucial enzyme in the blood clotting cascade.
Apixaban has been shown to be effective in reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and in reducing the risk of recurrent venous thromboembolism (VTE).
The medication is available in oral tablet form and is typically taken twice daily.
Apixaban is often compared to other anticoagulants like Rivaroxaban, which is another direct factor Xa inhibitor.
Researchers can utilize PubCompare.ai's innovative tools, such as AI-driven protocol comparisons and literature/patent searches, to optimize their Apixaban studies and improve research outcomes.
When conducting Apixaban research, it's important to consider related terms and assays like STA®-Liquid Anti-Xa, HemosIL, and STA-ECA II, which can be used to measure the anticoagulant effect of Apixaban.
Additionally, statistical software like SAS version 9.4 can be leveraged for data analysis.
Experiance better research outcomes with PubCompare.ai's cutting-edge tools designed to enhance the efficiency and accuracy of Apixaban studies.