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Condition: Hemorrhagic Stroke
Management: Food and Drug Administration (FDA)

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Total 40 results found since Jan 2013.

Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study
Discussion: The results of the TRACE study will provide preliminary evidence for the relationship between XNJI used within 24 h of onset and the presence of END on the third day after stroke onset; it will aid in improving the current knowledge regarding the early use of XNJI for stroke first aid.Clinical Trial Registration:clinicaltrials.gov, identifier NCT04275349
Source: Frontiers in Pharmacology - August 29, 2022 Category: Drugs & Pharmacology Source Type: research

Inhibiting ferroptosis: A novel approach for stroke therapeutics.
Abstract Stroke ranks as the second leading cause of death across the globe. Despite advances in stroke therapeutics, no US Food and Drug Administration (FDA)-approved drugs that can minimize neuronal injury and restore neurological function are clinically available. Ferroptosis, a regulated iron-dependent form of nonapoptotic cell death, has been shown to contribute to stroke-mediated neuronal damage. Inhibitors of ferroptosis have also been validated in several stroke models of ischemia or intracerebral hemorrhage. Herein, we review the therapeutic activity of inhibitors of ferroptosis in stroke models. We furth...
Source: Drug Discovery Today - January 4, 2021 Category: Drugs & Pharmacology Authors: Jin Y, Zhuang Y, Liu M, Che J, Dong X Tags: Drug Discov Today Source Type: research

Hemorrhagic Stroke in a Young Healthy Male Following Use of Pre-Workout Supplement Animal Rage XL.
Authors: Harris BF, Winn C, Ableman TB Abstract So-called "pre-workout" supplements are substances marketed as natural dietary supplements with claims of helping athletes achieve more focused and intense workouts. The use of such products remains popular among American youth as a whole, but is especially high among active duty service members. Supplements are minimally regulated by the Food and Drug Administration (FDA), and unlike pharmaceuticals, supplements are often brought to market without any testing to show neither efficacy nor safety. Several case reports have documented serious adverse events and raise th...
Source: Military Medicine - September 10, 2017 Category: International Medicine & Public Health Tags: Mil Med 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

State-of-the-Art Endovascular Treatment of Acute Ischemic Stroke.
Authors: Raphaeli G, Mazighi M, Pereira VM, Turjman F, Striefler J Abstract Stroke is the third leading cause of death in the USA. An estimated 795,000 new or recurrent stroke events occur annually, mostly ischemic in nature. Arterial recanalization and subsequent reperfusion performed shortly after symptom onset can help to restore brain function in acute ischemic stroke (AIS). The only treatment currently approved by the United States Food and Drug Administration is intravenous tissue plasminogen activator, administered within 4.5 h of symptom onset. However, this short window often precludes effective interventi...
Source: Advances and Technical Standards in Neurosurgery - December 1, 2014 Category: Neurosurgery Tags: Adv Tech Stand Neurosurg Source Type: research

Relevance of the Updated Food and Drug Administration Alteplase Label for Acute Ischemic Stroke: The Estimated Impact and Current Guidelines.
Abstract In 2015, the Food and Drug Administration updated the contraindications for the use of alteplase in acute ischemic stroke (AIS), potentially creating a greater impact on treatment. A history of intracranial hemorrhage and recent stroke within 3 months were removed as contraindications, increasing the number of patients eligible for alteplase. The aim of this commentary is to call attention to the updates and discuss them relative to current American Heart Association/American Stroke Association guidelines. Additionally, we estimate the clinical impact of the updates by analyzing AIS admissions to a large-...
Source: The Annals of Pharmacotherapy - January 1, 2018 Category: Drugs & Pharmacology Authors: Shiue HJ, Albright KC, Sands KA Tags: Ann Pharmacother Source Type: research

Tenecteplase for Acute Ischemic Stroke Treatment
Semin Neurol DOI: 10.1055/s-0040-1722722The introduction of thrombolytic therapy in the 1990s has transformed acute ischemic stroke treatment. Thus far, intravenous recombinant tissue plasminogen activator (rt-PA) also known as alteplase is the only thrombolytic proven to be efficacious and approved by the United States Food and Drug Administration. But the thrombolytic agent tenecteplase (TNK) is emerging as a potential replacement for rt-PA. TNK has greater fibrin specificity, slower clearance, and higher resistance to plasminogen activator inhibitor-1 than rt-PA. Hence, TNK has the potential to provide superior lysis wi...
Source: Seminars in Neurology - January 20, 2021 Category: Neurology Authors: Baird, Alison E. Jackson, Richard Jin, Weijun Tags: Review Article Source Type: research

tPA and warfarin: Time to move forward
The appropriate use of IV tissue plasminogen activator (tPA) for patients with acute ischemic stroke remains an area of active discussion among health care professionals. Since its approval in the United States by the Food and Drug Administration in 1996, the medical community has continued to review and discuss the risks vs benefits of this important therapy. Two recent publications1,2 and accompanying editorials have refocused attention on the vexing issue of using IV tPA in patients taking warfarin. The Xian et al.1 study found a 1.1% absolute increase in the risk of intracranial hemorrhage (ICH) with warfarin use (5.7%...
Source: Neurology - February 4, 2013 Category: Neurology Authors: Alberts, M. J., Naidech, A. M. Tags: All Cerebrovascular disease/Stroke EDITORIALS Source Type: research

UCLA-led study finds devices no better than meds in recovery from clot-caused strokes
When someone has a stroke, time equals brain. The longer a stroke is left untreated, the more brain tissue is lost. Since the only proven treatment — a clot-busting drug — works in less than half of patients, stroke physicians had high hopes for a mechanical device that could travel through the blocked blood vessel to retrieve or break up the clot, restoring blood flow to the brain.   But in a recently completed multi-site trial in which UCLA served as the clinical coordinating center, researchers found there was no overall recovery benefit to patients treated with clot-removal (embolectomy) devices, compa...
Source: UCLA Newsroom: Health Sciences - March 13, 2013 Category: Universities & Medical Training Source Type: news

Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Percutaneous devices for left atrial appendage occlusion: A contemporary review.
Abstract Patient with atrial fibrillation (AF) are at risk of developing stroke with the left atrial appendage (LAA) being the most common site for thrombus formation. If left untreated, AF is associated with 4 to 5 folds increase in the risk of ischemic stroke in all age groups. About 5% to 15% of AF patients have atrial thrombi on transesophageal echocardiography, and 91% of those thrombi are located in the LAA in patient with nonrheumatic AF. Although oral anticoagulants are the gold-standard treatment for stroke prevention in patients with non-valvular AF, some patients are at high risk of bleeding and deemed ...
Source: World Journal of Cardiology - February 25, 2019 Category: Cardiology Authors: Moussa Pacha H, Al-Khadra Y, Soud M, Darmoch F, Moussa Pacha A, Alraies MC Tags: World J Cardiol Source Type: research

Oral Anticoagulation in Atrial Fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Oral anticoagulation in atrial fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - December 5, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem 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

Will unpredictable side effects dim the promise of new Alzheimer ’s drugs?
A sea change is underway in the treatment of Alzheimer’s disease, where for the first time a drug that targets the disease’s pathology and clearly slows cognitive decline has hit the U.S. market. A related therapy will likely be approved in the coming months. As many neurologists, patients, and brain scientists celebrate, they’re also nervously eyeing complications from treatment: brain swelling and bleeding, which in clinical trials affected up to about one-third of patients and ranged from asymptomatic to fatal. The side effect—amyloid-related imaging abnormalities, or ARIA—remains mysterious. “We don’...
Source: Science of Aging Knowledge Environment - August 2, 2023 Category: Geriatrics Source Type: research