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Condition: Thrombosis
Management: Food and Drug Administration (FDA)

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Total 103 results found since Jan 2013.

The new oral anticoagulants: clinical use and reversal agent development
Warfarin has been the centre of oral anticoagulant therapy for over 60 years. Recent development of new oral anticoagulants (NOACs) has provided a safe and effective alternative for stroke prevention in patients with atrial fibrillation and for prevention of venous thromboembolism. Determination of their use in acute coronary syndrome has been hampered by increases in bleeding events in most large trials, especially when used with antiplatelet therapy. NOACs have equal or superior efficacy and safety profiles compared to warfarin, fewer drug interactions; no dietary restrictions; predictable responses that eliminates moni...
Source: ISBT Science Series - April 13, 2015 Category: Hematology Authors: J. Costin, J. Ansell, S. Bakhru, B. Laulicht, S. Steiner Tags: Invited Review 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

Why You Should Avoid Statins
At my anti-aging clinic, I continue to wage war against what I call the “medical-industrial complex.” And I do it for one reason only – I care more about my patients than I do about profits. Big Pharma clearly takes the opposite view. And now it seems these pharmaceutical behemoths won’t be happy until every man, woman and child is popping anti-cholesterol pills. Researchers at Duke University recently issued a report recommending that even children and people as young as 30 should be on statins, if they have just slightly elevated cholesterol levels.1 And why wouldn’t researchers at Duke recommen...
Source: Al Sears, MD Natural Remedies - February 3, 2015 Category: Complementary Medicine Authors: Dr. Al Sears Tags: Heart Health Source Type: news

Recent Advances in the Development of Specific Antidotes for Target‐Specific Oral Anticoagulants
Warfarin, a vitamin K antagonist, has been the only orally available anticoagulant for > 60 years. During the past decade, the U.S. Food and Drug Administration has approved several target‐specific oral anticoagulants (TSOACs) for the prophylaxis and treatment of arterial and venous thromboembolism and stroke prevention in patients with nonvalvular atrial fibrillation. These new agents have several advantages over warfarin including more predictable pharmacokinetics and pharmacodynamics, fewer food and drug interactions, and lack of need for routine coagulation monitoring. However, unlike warfarin, currently no ant...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - February 3, 2015 Category: Drugs & Pharmacology Authors: Yoonsun Mo, Felix K. Yam Tags: Review of Therapeutics Source Type: research

Practical aspects of treatment with target specific anticoagulants: initiation, payment and current market, transitions, and venous thromboembolism treatment
Abstract Target specific anticoagulants (TSOACs) have recently been introduced to the US market for multiple indications including venous thromboembolism (VTE) prevention in total hip and knee replacement surgeries, VTE treatment and reduction in the risk of stroke in patients with non-valvular atrial fibrillation (NVAF). Currently, three TSOACs are available including rivaroxaban, apixaban, and dabigatran with edoxaban currently under Food and Drug Administration review for VTE treatment and stroke prevention in NVAF. The introduction of these agents has created a paradigm shift in anticoagulation by considerably...
Source: Journal of Thrombosis and Thrombolysis - January 21, 2015 Category: Hematology Source Type: research

Development of the Trevo ProVue Retriever for intracranial clot removal in acute ischemic stroke
It is estimated that 15 million people worldwide have a stroke each year. Of the estimated 795,000 strokes that occur in the United States annually, the majority are ischemic strokes resulting from an obstruction within a vessel supplying blood to the brain. The treatment goal for these patients is to restore blood flow as quickly as possible. Increasingly, endovascular treatments that interact directly with the clot are being pursued as options. Receiving U.S. Food and Drug Administration clearance in 2012, the Trevo® Retriever is a stent‐like structure to be deployed at the site of an occlusion to allow the occluding ...
Source: Annals of the New York Academy of Sciences - November 14, 2014 Category: Science Authors: Heather C. Prince, Amelia J. Saliba, Jaime Wheeler, Scott Bruder Tags: Original Article Source Type: research

Early Ischemic Blood Brain Barrier Damage: A Potential Indicator for Hemorrhagic Transformation Following Tissue Plasminogen Activator (tPA) Thrombolysis?
Abstract Tissue plasminogen activator (tPA) thrombolysis, remains the only United States Food and Drug Administration(FDA) approvedtreatmentfor acute ischemia stroke. However, the use of tPA has been profoundly constraineddue to its narrow therapeutic time window and the increased risk of potentially deadly hemorrhagic complications. TPA-associated hemorrhagic transformation (HT) often occurs as a result of catastrophic failure of theblood brain barrier (BBB), wherein the affected cerebral capillaries can no longer hold blood constituents.Due to its direct contribution to edema and HT, reperfusion-associated BBB d...
Source: Current Neurovascular Research - May 30, 2014 Category: Neurology Authors: Jin X, Liu J, Liu W Tags: Curr Neurovasc Res Source Type: research

Parent artery reconstruction for large or giant cerebral aneurysms using a Tubridge flow diverter (PARAT): study protocol for a multicenter, randomized, controlled clinical trial
This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion...
Source: BioMed Central - May 4, 2014 Category: Journals (General) Authors: Yu ZhouPeng-Fei YangYi-Bin FangYi XuBo HongWen-Yuan ZhaoQiang LiRui ZhaoQing-Hai HuangJian-Min Liu Source Type: research

The New Era of Anticoagulation
This article reviews the literature on these novel anticoagulants, including their pharmacokinetics and treatment indications.
Source: Annals of Vascular Surgery - January 10, 2014 Category: Surgery Authors: Nedaa Skeik, Kyle K. Rumery, Gabriel T. Rodriguez Tags: General Review Source Type: research

Stroke Prevention in Atrial Fibrillation: Impact of Novel Oral Anticoagulants
New orally administered anticoagulants will simplify stroke-prevention strategies in patients with atrial fibrillation (AF). Novel anticoagulants, such as dabigatran etexilate, a direct thrombin inhibitor, and rivaroxaban, a direct factor Xa inhibitor, have been approved by the US Food and Drug Administration for the prevention of stroke and systemic embolism in patients with nonvalvular AF. In addition, the factor Xa inhibitor apixaban has been reported to be as effective as warfarin in a large, randomized clinical trial, and the efficacy of edoxaban is being assessed in a phase III warfarin comparison trial. This review ...
Source: Clinical and Applied Thrombosis/Hemostasis - June 3, 2013 Category: Hematology Authors: Haft, J. I. Tags: Review Source Type: research

Anticoagulation for non-valvular atrial fibrillation: new anticoagulant agents.
Abstract Atrial fibrillation (AF) is a common cardiac arrhythmia and it is associated with systemic thromboembolism. Until recently, vitamin K antagonists (VKA) such as warfarin were the only available oral anticoagulant therapy for prevention of stroke and systemic embolism in AF. Limitations of VKA therapy have prompted researchers to search for novel anticoagulant drugs, which do not necessitate coagulation monitoring due to their more predictable pharmacokinetic profile. Large-scale phase III trials have been completed for some of these drugs and 'U.S. Food and Drug Administration (FDA)' approved dabigatran an...
Source: The Anatolian Journal of Cardiology - April 11, 2013 Category: Cardiology Authors: Kepez A, Erdoğan O Tags: Anadolu Kardiyol Derg 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

Managing Blunt Trauma in Patients Receiving Dabigatran Etexilate: Case Study and Review of the Literature
The objectives of this article are to present a case of life-threatening bleeding in a patient receiving dabigatran etexilate, followed by a review of the current literature and a suggested reversal guideline.
Source: Journal of Emergency Nursing: JEN - April 1, 2013 Category: Nursing Authors: Peter Eamonn Croft, Katherine P. Cabral, Tania D. Strout, Michael R. Baumann, Michael A. Gibbs, Matthew C. DeLaney Tags: Trauma Notebook Source Type: research