- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Clinical, Journal: Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome. (Pubmed Central) - Aug 15, 2019
For TIMI major bleeding events, a statistically significant association was observed with C [HR, 1.08; 95% CI, 1.06-1.11 (95th percentile versus median, 2.5 mg twice daily)], sex [HR, 0.56; 95% CI, 0.38-0.84 (female versus male)], and previous revascularization [HR, 0.62; 95% CI, 0.44-0.87 (no versus yes)]. The shallow slopes of the exposure-response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics.
- |||||||||| rivaroxaban / Generic mfg.
Trial completion date, Trial primary completion date: RIVA-PCI: Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI (clinicaltrials.gov) - Aug 14, 2019
P=N/A, N=2100, Recruiting,
The shallow slopes of the exposure-response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics. Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: May 2019 --> Oct 2019
- |||||||||| rivaroxaban / Generic mfg., warfarin / Generic mfg., apixaban / Generic mfg.
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: COVET: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (clinicaltrials.gov) - Aug 14, 2019
P4, N=44, Terminated,
Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: May 2019 --> Oct 2019 N=3000 --> 44 | Trial completion date: Oct 2021 --> May 2019 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> May 2019; Lack of enrollment
- |||||||||| rivaroxaban / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: TRIM-Line: Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (clinicaltrials.gov) - Aug 14, 2019
P3, N=50, Recruiting,
N=3000 --> 44 | Trial completion date: Oct 2021 --> May 2019 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> May 2019; Lack of enrollment Not yet recruiting --> Recruiting | Trial completion date: Dec 2018 --> Apr 2020 | Trial primary completion date: Oct 2018 --> Dec 2019
- |||||||||| warfarin / Generic Mfg.
Review, Journal: Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Comment. (Pubmed Central) - Aug 9, 2019
We respond to comments by Dufrost et al. about the RAPS trial, in particular, showing that the trial did achieve its target sample size; pointing out that thrombin potential is not synonymous with overall thrombin generation; confirming that overall, no increased thrombotic risk was evident comparing rivaroxaban with warfarin; and that high-risk patients (28% were triple positive, representative of patients with venous thromboembolism requiring standard-intensity anticoagulation) were included; and clarifying our rationale for using a laboratory surrogate primary outcome measure instead of a clinical one.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Journal: Rivaroxaban plus Aspirin ist zur Prävention von Schlaganfällen wirksamer als Aspirin allein, aber auch gefährlicher. (Pubmed Central) - Aug 8, 2019
about the RAPS trial, in particular, showing that the trial did achieve its target sample size; pointing out that thrombin potential is not synonymous with overall thrombin generation; confirming that overall, no increased thrombotic risk was evident comparing rivaroxaban with warfarin; and that high-risk patients (28% were triple positive, representative of patients with venous thromboembolism requiring standard-intensity anticoagulation) were included; and clarifying our rationale for using a laboratory surrogate primary outcome measure instead of a clinical one. No abstract available
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Push Enteroscopy in the Diagnosis of a Gastrointestinal Bleed Caused by Diffuse Large B-Cell Lymphoma (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2729;
Case Description/ A 77 year old female with a past medical history of gastric carcinoid, iron deficiency anemia, and history of pulmonary embolism now on rivaroxaban had presented after a syncopal episode...While small bowel tumors are among the most common causes of obscure GI bleed in young patient, this is a rare finding in the elderly. As this case demonstrates though, the possibility of malignancy should not be overlooked.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
An Uncommon Etiology for Gastrointestinal Bleed in Elderly: Blue Rubber Bleb Nevus Syndrome (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2714;
Case Description/ 87-year-old man with a past medical history of hypertension, coronary artery disease and atrial fibrillation (on Xarelto) was transferred to our hospital for evaluation of melena...Push endoscopy is the most important diagnostic modality for GI lesions. Treatment depends on the severity of lesions and can range from supportive therapies such as iron supplementation and blood transfusion to more invasive therapies such as mucosal resection, APC, sclerotherapy or bowel resection.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
A Case of Extreme Fatty Expulsion Per Rectum (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2431;
Case Description/ A 48-year-old male with a past medical history of a partial small bowel obstruction & atrial fibrillation (AF) on rivaroxaban presented to ED with complaints of intermittent abdominal pain & an abnormal bloody bowel movement...This case & its findings demonstrate that spontaneous expulsion of a lipoma can occur via similar mechanisms of auto-amputation for polyps as previous cases have shown. It also reminds us the relationship between abdominal pathologies & the propensity for AF.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Rare Finding of Incidental Ascending Colon Ganglioneuroma in the Setting of Hematochezia (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1565;
Case Description/ 84 year old male with a past medical history of hypertension, chronic atrial fibrillation on rivaroxaban, COPD, and prostate cancer S/P radiation presented with hematochezia of two days duration...Polypoid ganglioneuroma, which is present in this patient, is a benign lesion, so endoscopic resection using a biopsy forceps or a snare is usually curative. It may also be useful to perform a follow up colonoscopy to ensure complete excision of the lesion.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J, fondaparinux / Generic Mfg.
Pancreatic Cancer: Leading to Failure of Rivaroxaban as an Anticoagulant (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1465;
Patient was then switched to fondaparinux and it helped her from keep getting recurrent VTE exacerbation...Conversely, NOACs were invented to provide innocuous and more compliant alternative to warfarin and enoxaparin...Nonetheless, few case reports are out that don’t support Rivaroxaban’s effectiveness as a prophylactic agents for preventing VTE. We propose that it still requires more post-marketing research in assessing Rivaroxaban’s real efficacy/effectiveness as prophylactic agent for VTE in Pancreatic as well as other cancers.
- |||||||||| dexamethasone / generics
Iatrogenic Lingual Hematoma Resulted in Impending Airway Compromise (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1462;
We describe a rare case of iatrogenic large tongue hematoma in a patient on Rivaroxaban after securing the endotracheal tube tightly with a thread for an ERCP...He was treated with IV dexamethasone, famotidine, and diphenhydramine, and was transferred to the ICU for closer observation...Lingual hematoma should be identified early to avoid impending airway compromise. Recognition of this potential complication by anesthesiologists and interventional endoscopists is necessary to prevent it.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
A Case of Pancreatic Pseudoaneurysm (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1450;
Case Description/ 30-year old male with history of alcohol abuse, chronic pancreatitis, and splenic vein thrombosis on Xarelto presented to emergency department with epigastric pain...Surgery is necessary when embolization is unsuccessful. Prompt diagnosis and early treatment of pancreatic pseudoaneurysm is mandatory because of potentially life-threatening consequences and increased mortality if left untreated.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J, ALT-804 / Altor BioSci
Pseudocirrhosis in Subacute/Chronic Budd-Chiari Syndrome With JAK 2 Mutation (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1448;
Labs on admission revealed WBC 18.4, HGB 16.8, PLT 588, AST 570, ALT 804 and TB 4.6...Patient was discharged on daily oral Rivaroxaban with intermittent therapeutic paracentesis...Subacute/chronic BCS may present with cirrhotic complications like portal hypertension, ascites and variceal bleeding. Apart from anticoagulation, these patients may require other interventions to bypass the obstruction like Direct Intrahepatic Portosystemic Shunt (DIPS) placement.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Stelara (ustekinumab) / J&J
A Rare Case of IgA Vasculitis Secondary to Infliximab Use in Crohn’s Disease (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1018;
She was initiated on oral Prednisone 1mg/kg/day...She was treated with anticoagulation for the aortic thrombus with IV heparin and then later transitioned to oral Rivaroxaban...Regarding the Crohn’s disease, a decision was made to switch her therapy from IFX to Ustekinumab for maintenance of remission...The resolution of symptoms may be achieved by discontinuing use of the culprit anti-TNF agent and initiating adjuvant treatment. Alternative non-anti-TNF therapies should be pursued for definitive treatment.
- |||||||||| CMV Colitis Superimposed on Ischemic Colitis in an Immunocompetent Individual (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1009;
Case Description/ A 68-year-old man with history of PE (on Xarelto), pneumothorax & COPD presented with 10 weeks of diarrhea, associated with chills, lower abdominal discomfort, poor appetite, and weight loss of 15 pounds...Patient was started on PO Prednisone 60 mgs daily & Pentasa TID and discharged for close follow up with GI...IV Ganciclovir was initiated, steroids were discontinued...This is an unusual case of CMV associated ischemic colitis in an immunocompetent individual. This case report also should sound an alarm to GI physicians on thinking about CMV colitis infections even in immunocompetent individuals.
- |||||||||| Flagyl (metronidazole) / SLA, ceftriaxone / Generic Mfg.
Cheers to Budd: Pyogenic Liver Abscess Complicated by Acute Budd-Chiari Syndrome (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_551;
Fluid serology was positive for Entamoeba histolytica and only metronidazole was continued for 21 days, along with rivaroxaban for six months for the treatment of Budd Chiari syndrome...Underlying prothrombotic affection must be excluded. To conclude, identifying a treatable cause of Budd-Chiari syndrome, such as liver abscess, can result in early, effective, and life-saving treatment.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Clinical, Journal, Adverse events: Major Adverse Limb Events in Lower Extremity Peripheral Artery Disease: COMPASS Trial. (Pubmed Central) - Aug 8, 2019
P3
Among individuals with lower extremity PAD, the development of MALE is associated with a poor prognosis, making its prevention of utmost importance. The combination of rivaroxaban 2.5 mg bid and aspirin significantly lowers the incidence of MALE and its related complications and should be considered as an important therapy for patients with PAD.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Journal: Effect of rivaroxaban starter packs on emergency department throughput. (Pubmed Central) - Aug 7, 2019
The combination of rivaroxaban 2.5 mg bid and aspirin significantly lowers the incidence of MALE and its related complications and should be considered as an important therapy for patients with PAD. No abstract available
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Clinical, Review, Journal: Development of New Antithrombotic Regimens for Patients with Acute Coronary Syndrome. (Pubmed Central) - Aug 7, 2019
Two studies have investigated the role of NOACs in combination with a P2Y inhibitor, with or without ASA, in reducing bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention; two further studies are underway. Although these trials will help to inform optimal treatment protocols for secondary prevention of ACS, an individualized approach to treatment will be needed, taking account of the high frequency of co-morbid conditions found in this patient population.
- |||||||||| rivaroxaban / Generic mfg., dabigatran etexilate / Generic mfg., apixaban / Generic mfg.
Clinical, Journal: Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant. (Pubmed Central) - Aug 6, 2019
In patients with a high-bleeding-risk procedure, the rates of major bleeding were 2.96% (95% CI, 0%-4.68%) in the apixaban cohort and 2.95% (95% CI, 0%-4.76%) in the rivaroxaban cohort. In this study, patients with AF who had DOAC therapy interruption for elective surgery or procedure, a perioperative management strategy without heparin bridging or coagulation function testing was associated with low rates of major bleeding and arterial thromboembolism.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J, Pradaxa (dabigatran etexilate) / Boehringer Ingelheim
Journal: In vitro efficacy of pro- and anticoagulant strategies in compensated and acutely ill patients with cirrhosis. (Pubmed Central) - Aug 3, 2019
These in vitro data suggest little prohemostatic effect of fresh frozen plasma and recombinant factor VIIa in acutely ill cirrhotics, whereas prothrombin complex concentrate and fibrinogen concentrate clearly improved hemostasis. Furthermore, our data suggest the requirement for dose-adjustments of commonly used anticoagulants in these patients.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Journal: Pharmaceutical diversification via palladium oxidative addition complexes. (Pubmed Central) - Aug 3, 2019
OACs exhibit remarkable stability, maintaining their reactivity after months of benchtop storage under ambient conditions. We demonstrated the utility of OACs in a variety of experiments including automated nanomole-scale couplings between an OAC derived from rivaroxaban and hundreds of diverse nucleophiles, as well as the late-stage derivatization of the natural product k252a.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo
Enrollment change, Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world: ReLoaDeD: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon (clinicaltrials.gov) - Aug 2, 2019
P=N/A, N=90000, Not yet recruiting,
We demonstrated the utility of OACs in a variety of experiments including automated nanomole-scale couplings between an OAC derived from rivaroxaban and hundreds of diverse nucleophiles, as well as the late-stage derivatization of the natural product k252a. N=64920 --> 90000 | Trial completion date: Nov 2018 --> Jan 2020 | Trial primary completion date: Nov 2018 --> Jan 2020
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Journal: Pulmonary embolism four days after interruption of therapy with rivaroxaban. (Pubmed Central) - Aug 1, 2019
...He had received 40 mg enoxaparin/d...He recovered with low-molecular-weight heparin in therapeutic dosages and amiodarone and was discharged with phenprocoumon...It should be assessed if rebound-phenomena also exist for the NOACs dabigatran, apixaban and edoxaban. Thus, the randomized trials and registries investigating patients with AF or venous thromboembolism should be re-analysed and, based on these data, recommendations should be developed for situations in which NOAC-therapy has to be interrupted or ceased.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Clinical, Journal: Risk Factors for Higher-than-Expected Residual Rivaroxaban Plasma Concentrations in Real-Life Patients. (Pubmed Central) - Aug 1, 2019
In our group of real-life patients, impaired kidney function (GFR < 60 mL/min) and co-medication with amiodarone were independently associated with higher-than-expected residual RXA plasma concentrations. In these patients, standard intervals of RXA discontinuation may not always be sufficient before elective surgery and routine pre-operative determination of the residual RXA concentration could be advisable.
- |||||||||| Xarelto (rivaroxaban) / Bayer, J&J
Clinical, Journal: Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. (Pubmed Central) - Aug 1, 2019
P3
The use of rivaroxaban in high-risk patients with Antiphospholipid Syndrome was associated with an increased rate of events as compared with warfarin, thus showing no benefit and excess risk. (ClinicalTrials.gov Identifier: NCT02157272).
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