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Condition: Hemorrhagic Stroke
Management: European Medicines Agency (EMA)

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Total 12 results found since Jan 2013.

Severe ischemic stroke: Too severe for thrombolysis?
Twenty years after the introduction of IV thrombolysis with recombinant tissue plasminogen activator (rtPA), only a small proportion of stroke patients are treated with rtPA.1 The strict inclusion and exclusion criteria in the stroke guidelines, based on criteria used in the rtPA trials, partially explains the low number of treated patients. Fear of intracranial hemorrhage after rtPA also drives the strict selection of patients, despite evidence of the safety and potential effectiveness of rtPA treatment in an off-label setting.2,3 According to the European Medicines Agency, very severe stroke, defined as an NIH Stroke Sca...
Source: Neurology - December 14, 2015 Category: Neurology Authors: Uyttenboogaart, M., Fink, J. N. Tags: Stroke in young adults, Class III, Infarction, Intracerebral hemorrhage EDITORIALS Source Type: research

The Burden of Diabetes and the Chance of a Previous Stroke: Thrombolysis for Recurrent Stroke in Diabetics
Intravenous thrombolysis with recombinant tissue plasminogen activator is still not approved by the European Medicines Agency for patients with diabetes mellitus and previous stroke. We assessed functional benefit and potential risk of thrombolysis in patients with diabetes and previous stroke and the influence of age, preexisting diabetic damage, as well as acute and chronic hyperglycemia on outcome, symptomatic intracranial hemorrhage, and in-hospital mortality.
Source: Journal of Stroke and Cerebrovascular Diseases - February 3, 2018 Category: Neurology Authors: Alexandra Filipov, Anne D. Ebert, Eva Neumaier-Probst, Angelika Alonso Source Type: research

Practical use of dabigatran etexilate for stroke prevention in atrial fibrillation
Summary Atrial fibrillation (AF) is associated with an increased risk of thromboembolism, and is the most prevalent factor for cardioembolic stroke. Vitamin K antagonists (VKAs) have been the standard of care for stroke prevention in patients with AF since the early 1990s. They are very effective for the prevention of cardioembolic stroke, but are limited by factors such as drug–drug interactions, food interactions, slow onset and offset of action, haemorrhage and need for routine anticoagulation monitoring to maintain a therapeutic international normalised ratio (INR). Multiple new oral anticoagulants have been develope...
Source: International Journal of Clinical Practice - April 5, 2013 Category: Internal Medicine Authors: K. Huber, S. J. Connolly, A. Kher, F. Christory, G.‐A. Dan, R. Hatala, R. G. Kiss, B. Meier, B. Merkely, B. Pieske, T. Potpara, J. Stępińska, N. Vene Klun, D. Vinereanu, P. Widimský Tags: Consensus Source Type: research

Cost-effectiveness analysis of apixaban compared to other direct oral anticoagulants for prevention of stroke in Austrian atrial fibrillation patients.
CONCLUSION: In patients with AF and an increased risk of stroke, prophylaxis with apixaban was highly cost-effective from the perspective of the Austrian health care system. PMID: 32700584 [PubMed - as supplied by publisher]
Source: Expert Review of Pharmacoeconomics and Outcomes Research - July 24, 2020 Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res Source Type: research

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Clinical characteristics and outcomes of COMPASS eligible patients in France. An analysis from the REACH Registry.
CONCLUSION: The COMPASS therapeutic strategy in France appears to be applicable to more than half of CAD or PAD patients. This population appears at high residual risk of atherothrombotic events, and patients with polyvascular disease experienced the highest rate of events. PMID: 32778388 [PubMed - as supplied by publisher]
Source: Annales de Cardiologie et d'Angeiologie - August 6, 2020 Category: Cardiology Authors: Darmon A, Elbez Y, Bhatt DL, Abtan J, Mas JL, Cacoub P, Montalescot G, Billaut-Laden I, Ducrocq G, Steg PG Tags: Ann Cardiol Angeiol (Paris) Source Type: research

Tissue-type plasminogen activator-binding RNA aptamers inhibiting low-density lipoprotein receptor family-mediated internalisation.
Abstract Recombinant tissue-type plasminogen activator (tPA, trade name Alteplase), currently the only drug approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of cerebral ischaemic stroke, has been implicated in a number of adverse effects reportedly mediated by interactions with the low-density lipoprotein (LDL) family receptors, including neuronal cell death and an increased risk of cerebral haemorrhage. The tissue-type plasminogen activator is the principal initiator of thrombolysis in human physiology, an effect that is mediated directly via localised activation...
Source: Thrombosis and Haemostasis - April 9, 2015 Category: Hematology Authors: Bjerregaard N, Bøtkjær KA, Helsen N, Andreasen PA, Dupont DM Tags: Thromb Haemost Source Type: research

Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study
This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study – a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. Methods The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland,...
Source: Journal of Cardiovascular Medicine - January 3, 2019 Category: Cardiology Tags: Research articles: Trial design Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Reply: Association between triple therapy and major adverse cardiovascular events in COPD patients
We thank P. Almagro and P. Martinez-Camblor for their interest in our work and for their salient comments. While we agree that there is no universally accepted definition of major adverse cardiovascular event (MACE), the US Food and Drug Administration (FDA) and the European Medicines Agency include nonfatal myocardial infarction and stroke as well as cardiovascular (CV) mortality in their MACE definition [1]. Importantly, this definition includes both haemorrhagic and ischaemic stroke [1–4]. In our study, we followed this classical "three-point" definition of MACE (including haemorrhagic strokes). While this definit...
Source: European Respiratory Journal - March 2, 2023 Category: Respiratory Medicine Authors: Yang, M.-J., Guo, S.-L., Sin, D. D. Tags: Correspondence Source Type: research

Diagnostic value of  alternative techniques to gadolinium-based contrast agents in MR neuroimaging—a comprehensive overview
AbstractGadolinium-based contrast agents (GBCAs) increase lesion detection and improve disease characterization for many cerebral pathologies investigated with MRI. These agents, introduced in the late 1980s, are in wide use today. However, some non-ionic linear GBCAs have been associated with the development of nephrogenic systemic fibrosis in patients with kidney failure. Gadolinium deposition has also been found in deep brain structures, although it is of unclear clinical relevance. Hence, new guidelines from the International Society for Magnetic Resonance in Medicine advocate cautious use of GBCA in clinical and resea...
Source: Insights into Imaging - August 22, 2019 Category: Radiology Source Type: research