Stroke trials

Despite the adverse effects and unclear benefit of the complete 21-day course of nimodipine therapy, The Joint Commission mandates adherence to nimodipine treatment for 21 days after hemorrhage or after hospital discharge if discharged within 21 days for Comprehensive Stroke Center (CSC) certification. We hereby present a 67 year-old male patient with Hunt-Hess grade 2 and Fisher grade 3 non-aneurysmal spontaneous subarachnoid hemorrhage who was discharged with oral nimodipine as stipulated by the CSC guidelines, and subsequently developed symptomatic hypotension...

BACKGROUND: In the PATHWAY-2 study of resistant hypertension, spironolactone reduced blood pressure substantially more than conventional antihypertensive drugs. We did three substudies to assess the mechanisms underlying this superiority and the pathogenesis of resistant hypertension. METHODS: PATHWAY-2 was a randomised, double-blind crossover trial done at 14 UK primary and secondary care sites in 314 patients with resistant hypertension. Patients were given 12 weeks of once daily treatment with each of placebo, spironolactone 25-50 mg, bisoprolol 5-10 mg, and doxazosin 4-8 mg and the change in home systolic blood pressure was assessed as the primary outcome...

BACKGROUND: The HeartMate 3 left ventricular assist system is engineered to avoid pump thrombosis, yet bleeding complications persist. We investigated the safety of low-intensity anti-coagulation in patients with the HeartMate 3. METHODS: The Minimal AnticoaGulation EvaluatioNTo aUgment heMocompatibility (MAGENTUM 1) pilot study is a prospective, single-arm study of low-intensity warfarin anti-coagulation in patients implanted with the HeartMate 3 pump. After standard warfarin anti-coagulation (international normalized ratio [INR] 2...

BACKGROUND: Current guidelines recommend transcatheter aortic valve replacement (TAVR) in patients with severe symptomatic aortic stenosis (AS) who are not suitable for conventional surgical aortic valve replacement (SAVR). In light of the recent trend in performing TAVR in patients with lower risk profile, we assessed the midterm outcome comparing TAVR and SAVR for the treatment of patients with severe AS at low to intermediate risk. METHODS: PubMed, EBSCO, and Cochrane CENTRAL were systematically searched for randomized controlled trials that reported the clinical outcomes of TAVR versus SAVR in patients at low to intermediate surgical risk with at least 2 years of follow-up...

BACKGROUND: In the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial of patients with non-ST-segment elevation acute coronary syndrome managed medically without revascularization, treated with prasugrel versus clopidogrel for less than or equal to 30 months after index acute coronary syndrome, post-hoc analyses showed a divergence of treatment effect in favor of prasugrel after 12 months. Potential influential factors, including a potential late treatment effect after early study drug discontinuation in the intention-to-treat analysis, have not been explored...

BACKGROUND: Alogliptin, a dipeptidyl-peptidase 4 inhibitor, is approved for the treatment of patients with type 2 diabetes. EXAMINE was a randomized-controlled clinical trial designed to demonstrate the cardiovascular safety of alogliptin. In the trial, 5380 patients with established T2DM who had a recent ACS event (between 15-90 days) were randomized to treatment with either alogliptin or placebo. HYPOTHESIS: To better understand and describe the cardiovascular (CV) safety of alogliptin, we analyzed data from the EXAMINE randomized clinical trial to determine whether treatment with alogliptin affected recurrent and total CV events...

Identification of factors in malignant middle cerebral artery (MMCA) stroke patients that may be useful in selecting patients for DHC. This study was a retrospective multicenter study of patients referred for DHC based on the criteria of the randomized control trials of DHC in MMCA stroke. Demographic, clinical, and radiology data were analyzed. Patients who underwent DHC were compared to those who survived without surgery. Two hundred three patients with MMCA strokes were identified: 137 underwent DHC, 47 survived without DHC, and 19 refused surgery and died...

BACKGROUND: Severe primary graft dysfunction (PGD) of grade 3 (PGD3) is a common serious complication following lung transplantation. We aimed to assess physiological donor lung preservation using the Organ Care System (OCS) Lung device compared with cold static storage. METHODS: In this non-inferiority, randomised, controlled, open-label, phase 3 trial (INSPIRE) recipients were aged 18 years or older and were registered as standard criteria primary double lung transplant candidates...

BACKGROUND: Stroke survivors are more physically inactive than even the most sedentary older adults, and low activity is associated with increased risk of recurrent stroke, medical complications, and mortality. We hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone...

In addition to monoclonal antibodies against proprotein convertase subtilisin-kexin type 9 (PCSK9), vaccines against PCSK9 and smaller molecule inhibitors as well as RNA inhibitors of PCSK9 production have been created. The monoclonal antibodies against PCSK9 and the PCSK9 RNA inhibitors can reduce low-density lipoproteins (LDLs) by over 50%, non-high-density lipoprotein (HDL) cholesterol and triglycerides, and increasing HDL. Although effective in several homozygous familial hypercholesterolemia patient types, PCSK9 inhibitors does not work in all patient types...

BACKGROUND: The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. SUMMARY: Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched...

There have been concerns that treatment of overactive bladder with β3 -adrenoceptor agonists may potentially have detrimental cardiovascular (CV) side effects. We evaluated the CV safety of mirabegron, a β3 -adrenoceptor agonist, alone and in combination therapy with the antimuscarinic agent solifenacin. The SYNERGY trial was a multinational, multicenter, randomized, double-blind, parallel-group, placebo and active-controlled phase 3 trial. Patients were randomized to receive solifenacin 5 mg + mirabegron 50 mg (combination 5 + 50 mg), solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg monotherapy, mirabegron 25 mg monotherapy, mirabegron 50 mg monotherapy, or placebo for a 12-week double-blind treatment period...

OBJECTIVE: To investigate the effects of mirror therapy on walking ability, balance and lower limb motor recovery in patients with stroke. METHOD: MEDLINE, EMBASE, Web of Science, CENTRAL, PEDro Database, CNKI, VIP, Wan Fang, ClinicalTrials.gov, Current controlled trials and Open Grey were searched for randomized controlled trials that investigated the effects of mirror therapy on lower limb function through January 2018. The primary outcomes included were walking speed, mobility and balance function...

BACKGROUND: We performed an updated meta-analysis of all randomized-controlled trials (RCTs) comparing patent foramen ovale (PFO) closure with medical therapy for prevention of recurrent ischemic stroke. METHODS AND RESULTS: We searched Medline, EMBASE, and Cochrane databases, and proceedings of international meetings for RCTs of patients with cryptogenic stroke and PFO comparing percutaneous PFO closure versus medical therapy for prevention of recurrent ischemic stroke...

[Purpose] This study examines how difference in sandy ground between firm ground influences the effects of gait training in patients with chronic stroke. [Subjects and Methods] A total of 28 patients with chronic stroke were evenly divided into experimental and control groups. Initial evaluation of the subjects was conducted by Timed Up & Go (TUG) and 6-Minute Walking Test (6MWT). Each patient in both groups received daily, 30-minute gait training on sandy ground and firm ground, five times each week, for a total of six weeks, after which reevaluation was conducted...

[Purpose] The aim of the present study was to evaluate the immediate effects of transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) on activity of the tibialis anterior muscle (TA) and static balance of individuals with hemiparesis stemming from stroke. [Subjects and Methods] A randomized, double-blind, crossover, clinical trial conducted with 30 individuals with chronic post-stroke hemiparesis. Median frequency of electrical activity of the TA were determined using electromyography in five contractions concentrics and Static balance (body sway velocity and frequency), both before and immediately after the intervention...

BACKGROUND AND PURPOSE: EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap's safety and efficacy compared with established stent retrievers. METHODS: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials...

OBJECTIVE: To critique the Head Positioning in Stroke Trial (HeadPoST) study methods in relation to preceding research findings in an aim to clarify the potential efficacy of positioning interventions and direction for future research. METHODS: Head positioning research prior to the conduct of HeadPoST was reviewed by a team of international stroke experts, and methods and findings were compared to HeadPoST. RESULTS: Methods used to select HeadPoST patients differ substantially from those used in original head positioning studies, in particular enrollment of all types of stroke...

BACKGROUND: Although utilization of anticoagulation in patients with atrial fibrillation (AF) has increased in recent years, contemporary data regarding thromboembolism and mortality incidence rates are limited outside of clinical trials. This study aimed to investigate the impact of the direct oral anticoagulants (DOACs) on the clinical outcomes of patients with AF included in the Tasmanian Atrial Fibrillation Study. METHODS: The medical records of all patients with a primary or secondary diagnosis of AF who presented to public hospitals in Tasmania, Australia, between 2011 and 2015, were retrospectively reviewed...

OBJECTIVE: Non-cardiac surgery is associated with perioperative cerebral complications (delirium, postoperative cognition dysfunction, stroke). While rare, these complications can lead to disabilities and deaths. Information is ambiguous as to whether pharmacological preoperative treatment exerts neuroprotection. We wished to systematically assess potential modulation by statins, lidocaine, ketamine or magnesium sulfate of the relative risk of cerebral complications in noncardiac surgery...