OBJECTIVE: Ischemic complications account for significant patient morbidity following aneurysmal subarachnoid hemorrhage (aSAH). The Prevention and Treatment of Vasospasm with Clazosentan (REACT) study was designed to assess the safety and efficacy of clazosentan, an endothelin receptor antagonist, in preventing clinical deterioration due to delayed cerebral ischemia (DCI) in patients with aSAH. METHODS: REACT was a prospective, multicenter, randomized, double-blind, phase 3 study. Eligible patients had aSAH secured by surgical clipping or endovascular coiling, and had presented with thick and diffuse clot on admission CT scan. Patients were randomized (1:1 ratio) to 15 mg/hour intravenous clazosentan or placebo within 96 hours of the aSAH for up to 14 days, in addition to standard of care treatment including oral or intravenous nimodipine. The primary efficacy endpoint was the occurrence of clinical deterioration due to DCI up to 14 days after initiation of the study drug. The main secondary endpoint was the occurrence of clinically relevant cerebral infarction at day 16 after study drug initiation. Other secondary endpoints included clinical outcome assessed on the modified Rankin Scale (mRS) and the Glasgow Outcome Scale-Extended (GOSE) at week 12 post-aSAH. Imaging and clinical endpoints were centrally adjudicated. RESULTS: A total of 409 patients were randomized between February 2019 and May 2022 across 74 international sites. Three patients did not start study treatment and were not included in the analysis set. The occurrence of clinical deterioration due to DCI was 15.8% (32/202 patients) in the clazosentan group and 17.2% (35/204 patients) in the placebo group, and the difference was not statistically significant (relative risk reduction [RRR] 7.2%, 95% CI -42.6% to 39.6%, p = 0.734). A nonsignificant RRR of 34.1% (95% CI -21.3% to 64.2%, p = 0.177) was observed in clinically relevant cerebral infarcts treated with clazosentan (7.4%, 15/202) versus placebo (11.3%, 23/204). Rescue therapy was less frequently needed for patients treated with clazosentan compared to placebo (10.4%, 21/202 vs 18.1%, 37/204; RRR 42.6%, 95% CI 5.4%-65.2%). A nonsignificant relative risk increase of 25.4% (95% CI -10.7% to 76.0%, p = 0.198) was reported in the risk of poor GOSE and mRS scores with clazosentan (24.8%, 50/202) versus placebo (20.1%, 41/204) at week 12 post-aSAH. Treatment-emergent adverse events were similar to those reported previously. CONCLUSIONS: Clazosentan administered for up to 14 days at 15 mg/hour had no significant effect on the occurrence of clinical deterioration due to DCI. Clinical trial registration no.: NCT03585270 (ClinicalTrials.gov) EU clinical trial registration no.: 2018-000241-39 (clinicaltrialsregister.eu).

• Klíčová slova
• aneurysm, cerebral ischemia, cerebral vasospasm, clazosentan, endothelin-1, subarachnoid hemorrhage, vascular disorders,
• MeSH
• dioxany * terapeutické užití   škodlivé účinky   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• intrakraniální vazospazmus etiologie   prevence a kontrola   farmakoterapie   diagnostické zobrazování   MeSH
• ischemie mozku * prevence a kontrola   etiologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• pyridiny * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• pyrimidiny * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• senioři MeSH
• subarachnoidální krvácení * komplikace   diagnostické zobrazování   MeSH
• sulfonamidy * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• tetrazoly * terapeutické užití   škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• clazosentan MeSH Prohlížeč
• dioxany * MeSH
• pyridiny * MeSH
• pyrimidiny * MeSH
• sulfonamidy * MeSH
• tetrazoly * MeSH

AIMS: Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. METHODS AND RESULTS: The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001). CONCLUSION: Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.

• Klíčová slova
• Atrial fibrillation, Edoxaban, Non-vitamin K oral anticoagulant, Real-world, Registry,
• MeSH
• antikoagulancia škodlivé účinky   MeSH
• cévní mozková příhoda * diagnóza   epidemiologie   prevence a kontrola   MeSH
• embolie * MeSH
• fibrilace síní * komplikace   diagnóza   farmakoterapie   MeSH
• inhibitory faktoru Xa MeSH
• ischemie mozku * prevence a kontrola   MeSH
• krvácení chemicky indukované   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• srdeční selhání * farmakoterapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Názvy látek
• antikoagulancia MeSH
• edoxaban MeSH Prohlížeč
• inhibitory faktoru Xa MeSH

BACKGROUND: Asundexian (Bayer AG, Leverkusen, Germany), an oral small molecule factor XIa (FXIa) inhibitor, might prevent thrombosis without increasing bleeding. Asundexian's effect for secondary prevention of recurrent stroke is unknown. METHODS: In this randomised, double-blind, placebo-controlled, phase 2b dose-finding trial (PACIFIC-Stroke), patients with acute (within 48 h) non-cardioembolic ischaemic stroke were recruited from 196 hospitals in 23 countries. Patients were eligible if they were aged 45 years or older, to be treated with antiplatelet therapy, and able to have a baseline MRI (either before or within 72 h of randomisation). Eligible participants were randomly assigned (1:1:1:1), using an interactive web-based response system and stratified according to anticipated antiplatelet therapy (single vs dual), to once daily oral asundexian (BAY 2433334) 10 mg, 20 mg, or 50 mg, or placebo in addition to usual antiplatelet therapy, and were followed up during treatment for 26-52 weeks. Brain MRIs were obtained at study entry and at 26 weeks or as soon as possible after treatment discontinuation. The primary efficacy outcome was the dose-response effect on the composite of incident MRI-detected covert brain infarcts and recurrent symptomatic ischaemic stroke at or before 26 weeks after randomisation. The primary safety outcome was major or clinically relevant non-major bleeding as defined by International Society on Thrombosis and Haemostasis criteria. The efficacy outcome was assessed in all participants assigned to treatment, and the safety outcome was assessed in all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04304508, and is now complete. FINDINGS: Between June 15, 2020, and July 22, 2021, 1880 patients were screened and 1808 participants were randomly assigned to asundexian 10 mg (n=455), 20 mg (n=450), or 50 mg (n=447), or placebo (n=456). Mean age was 67 years (SD 10) and 615 (34%) participants were women, 1193 (66%) were men, 1505 (83%) were White, and 268 (15%) were Asian. The mean time from index stroke to randomisation was 36 h (SD 10) and median baseline National Institutes of Health Stroke Scale score was 2·0 (IQR 1·0-4·0). 783 (43%) participants received dual antiplatelet treatment for a mean duration of 70·1 days (SD 113·4) after randomisation. At 26 weeks, the primary efficacy outcome was observed in 87 (19%) of 456 participants in the placebo group versus 86 (19%) of 455 in the asundexian 10 mg group (crude incidence ratio 0·99 [90% CI 0·79-1·24]), 99 (22%) of 450 in the asundexian 20 mg group (1·15 [0·93-1·43]), and 90 (20%) of 447 in the asundexian 50 mg group (1·06 [0·85-1·32]; t statistic -0·68; p=0·80). The primary safety outcome was observed in 11 (2%) of 452 participants in the placebo group versus 19 (4%) of 445 in the asundexian 10 mg group, 14 (3%) of 446 in the asundexian 20 mg group, and 19 (4%) of 443 in the asundexian 50 mg group (all asundexian doses pooled vs placebo hazard ratio 1·57 [90% CI 0·91-2·71]). INTERPRETATION: In this phase 2b trial, FXIa inhibition with asundexian did not reduce the composite of covert brain infarction or ischaemic stroke and did not increase the composite of major or clinically relevant non-major bleeding compared with placebo in patients with acute, non-cardioembolic ischaemic stroke. FUNDING: Bayer AG.

• MeSH
• antikoagulancia terapeutické užití   MeSH
• cévní mozková příhoda * farmakoterapie   prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• faktor XIa MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• ischemická cévní mozková příhoda * MeSH
• ischemie mozku * farmakoterapie   prevence a kontrola   MeSH
• krvácení chemicky indukované   farmakoterapie   MeSH
• lidé MeSH
• senioři MeSH
• trombóza * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• antikoagulancia MeSH
• faktor XIa MeSH
• inhibitory agregace trombocytů MeSH

OBJECTIVE: The clinical outcome of surgical extracranial internal carotid artery (eICA) recanalization may be adversely affected by intraoperative ischemia. Median nerve somatosensory evoked potential (SEP) amplitude correlates well with cerebral blood flow. Our study presents the value of intraoperative SEP and selective shunting in the prevention of intraoperative ischemia development during urgent eICA recanalization. METHODS: Prospective recruitment of patients with acute unilateral eICA occlusion. All underwent surgical recanalization with intraoperative monitoring of scalp median SEPs. Preoperative clinical findings, cerebral collaterals, and 3 month functional outcome were evaluated. RESULTS: The cohort consisted of 33 patients. Intraoperative SEP amplitude decreased significantly in 6 (18.2%). An intraluminal shunt was inserted twice (6.1%), surgical complications occurred in 6 (18.2%), intracerebral hemorrhage was not found. Favorable outcome 3 months after surgery according to the modified Rankin scale (mRS 0-2) was achieved in 28 (84.8%), 3 patients died (9.1%). CONCLUSIONS: Intraoperative SEP during urgent eICA recanalization seems to be beneficial. Thanks to the effective measure based on the intraoperative SEP changes, the clinical outcome in four(12.1%) could be positively affected. SIGNIFICANCE: The results suggest that selective shunting based on intraoperative median SEPs may prevent intraoperative ischemia and may improve overall outcome of urgent eICA recanalization.

• Klíčová slova
• Intraoperative monitoring, Ischemic stroke, Selective shunting, Somatosensory evoked potentials, Urgent recanalization,
• MeSH
• arteria carotis interna chirurgie   MeSH
• intraoperační neurofyziologická monitorace * MeSH
• ischemie mozku * prevence a kontrola   MeSH
• lidé MeSH
• nemoci arterie carotis * chirurgie   MeSH
• prospektivní studie MeSH
• somatosenzorické evokované potenciály fyziologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

The authors address the topic of antiplatelet therapy after a non-cardioembolic ischaemic stroke. They discuss some controversial issues in therapy such as monotherapy versus combination therapy, short-term versus long-term therapy and whether current therapy should be modified or continued in the event a patient has experienced a stroke. Other outstanding issues dealt with include e.g., the risk of such therapy in patients developing cerebral microbleeds. While consensus has been reached by experts regarding the utility of dual therapy in the initial period, divergent opinions exist as to the selection of drugs and therapy duration. Definition of the optimal strategy is hindered by the lack of evidence and robust data from clinical trials.

• Klíčová slova
• acetylsalicylic acid, clopidogrel, dipyridamole, dual therapy, monotherapy., parameters,
• MeSH
• Aspirin MeSH
• cévní mozková příhoda * prevence a kontrola   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• ischemická cévní mozková příhoda * MeSH
• ischemie mozku * prevence a kontrola   MeSH
• kombinovaná farmakoterapie MeSH
• lidé MeSH
• sekundární prevence MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• Aspirin MeSH
• inhibitory agregace trombocytů MeSH

BACKGROUND: We characterised the phenotypic consequence of genetic variation at the PCSK9 locus and compared findings with recent trials of pharmacological inhibitors of PCSK9. METHODS: Published and individual participant level data (300,000+ participants) were combined to construct a weighted PCSK9 gene-centric score (GS). Seventeen randomized placebo controlled PCSK9 inhibitor trials were included, providing data on 79,578 participants. Results were scaled to a one mmol/L lower LDL-C concentration. RESULTS: The PCSK9 GS (comprising 4 SNPs) associations with plasma lipid and apolipoprotein levels were consistent in direction with treatment effects. The GS odds ratio (OR) for myocardial infarction (MI) was 0.53 (95% CI 0.42; 0.68), compared to a PCSK9 inhibitor effect of 0.90 (95% CI 0.86; 0.93). For ischemic stroke ORs were 0.84 (95% CI 0.57; 1.22) for the GS, compared to 0.85 (95% CI 0.78; 0.93) in the drug trials. ORs with type 2 diabetes mellitus (T2DM) were 1.29 (95% CI 1.11; 1.50) for the GS, as compared to 1.00 (95% CI 0.96; 1.04) for incident T2DM in PCSK9 inhibitor trials. No genetic associations were observed for cancer, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, or Alzheimer's disease - outcomes for which large-scale trial data were unavailable. CONCLUSIONS: Genetic variation at the PCSK9 locus recapitulates the effects of therapeutic inhibition of PCSK9 on major blood lipid fractions and MI. While indicating an increased risk of T2DM, no other possible safety concerns were shown; although precision was moderate.

• Klíčová slova
• Genetic association studies, LDL-cholesterol, Mendelian randomisation, Phenome-wide association scan,
• MeSH
• anticholesteremika škodlivé účinky   terapeutické užití   MeSH
• biologické markery krev   MeSH
• celogenomová asociační studie MeSH
• cévní mozková příhoda epidemiologie   prevence a kontrola   MeSH
• down regulace MeSH
• dyslipidemie krev   farmakoterapie   epidemiologie   genetika   MeSH
• hodnocení rizik MeSH
• infarkt myokardu epidemiologie   prevence a kontrola   MeSH
• inhibitory serinových proteinas škodlivé účinky   terapeutické užití   MeSH
• ischemie mozku epidemiologie   prevence a kontrola   MeSH
• jednonukleotidový polymorfismus * MeSH
• LDL-cholesterol krev   MeSH
• lidé MeSH
• PCSK9 inhibitory * MeSH
• proproteinkonvertasa subtilisin/kexin typu 9 genetika   MeSH
• randomizované kontrolované studie jako téma MeSH
• rizikové faktory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• Research Support, N.I.H., Extramural MeSH
• Názvy látek
• anticholesteremika MeSH
• biologické markery MeSH
• inhibitory serinových proteinas MeSH
• LDL-cholesterol MeSH
• PCSK9 inhibitory * MeSH
• PCSK9 protein, human MeSH Prohlížeč
• proproteinkonvertasa subtilisin/kexin typu 9 MeSH

Despite a significant transformation of ischaemic stroke management, it remains one of the leading causes of death, disability, functional impairment and cognitive deficits. With the advent of intravenous thrombolysis and mechanical thrombectomy, stroke is not an untreatable disease, mostly occurring in older people, any more. The most common cause of cardioembolic strokes is atrial fibrillation or flutter and atrial fibrillation is the most prevalent arrhythmia.The aim of this short communication is to describe the methodology of the Czech stroke guidelines development.High-quality 2017 Australian Stroke Foundation stroke guideline was considered for adaptation and a new guideline was developed and disseminated.

• MeSH
• antikoagulancia aplikace a dávkování   MeSH
• cévní mozková příhoda farmakoterapie   prevence a kontrola   MeSH
• fibrilace síní farmakoterapie   MeSH
• ischemie mozku prevence a kontrola   MeSH
• lidé MeSH
• medicína založená na důkazech MeSH
• směrnice jako téma MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• antikoagulancia MeSH

BACKGROUND: Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. METHODS: We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding. RESULTS: A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001). CONCLUSIONS: Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding. (Funded by Bayer and Janssen Research and Development; NAVIGATE ESUS ClinicalTrials.gov number, NCT02313909 .).

• MeSH
• Aspirin škodlivé účinky   terapeutické užití   MeSH
• cévní mozková příhoda etiologie   prevence a kontrola   MeSH
• inhibitory agregace trombocytů škodlivé účinky   terapeutické užití   MeSH
• inhibitory faktoru Xa škodlivé účinky   terapeutické užití   MeSH
• intrakraniální embolie farmakoterapie   MeSH
• ischemie mozku prevence a kontrola   MeSH
• Kaplanův-Meierův odhad MeSH
• krvácení chemicky indukované   MeSH
• lidé středního věku MeSH
• lidé MeSH
• rivaroxaban škodlivé účinky   terapeutické užití   MeSH
• sekundární prevence metody   MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• Aspirin MeSH
• inhibitory agregace trombocytů MeSH
• inhibitory faktoru Xa MeSH
• rivaroxaban MeSH

Patients with atrial fibrillation (AF) are at an approximately 0.5% to 3% increased risk of thromboembolism during and immediately after catheter ablation. Treatment guidelines recommend periprocedural oral anticoagulation plus unfractionated heparin during ablation. Rivaroxaban and dabigatran are the only non-vitamin K oral anticoagulants for which there are randomized controlled trials assessing uninterrupted anticoagulation in patients undergoing catheter ablation of AF. Edoxaban, a direct factor Xa inhibitor, is noninferior vs warfarin for the prevention of stroke or systemic embolism with less major bleeding in patients with nonvalvular AF. The ELIMINATE-AF (Evaluation of Edoxaban Compared With VKA in Subjects Undergoing Catheter Ablation of Nonvalvular Atrial Fibrillation) trial is a multinational, multicenter, prospective, randomized, open-label, parallel-group, blinded-endpoint evaluation (PROBE) study to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for a dose reduction) vs vitamin K antagonists (VKA) in patients with nonvalvular AF undergoing catheter ablation (http://www.ClinicalTrials.gov: NCT02942576). A total of 560 patients are planned for randomization to edoxaban or VKA (2:1 ratio) to obtain 450 patients fully compliant with the protocol. Patients will complete 21 to 28 days of anticoagulation prior to the ablation and a 90-day post-ablation period. The primary efficacy endpoint is the composite of all-cause death, stroke, and major bleeding. The primary safety endpoint is major bleeding. A magnetic resonance imaging substudy will assess the incidence of silent cerebral lesions post-ablation. ELIMINATE-AF will define the efficacy and safety of edoxaban for uninterrupted oral anticoagulation during catheter ablation of AF.

• Klíčová slova
• Atrial Fibrillation, Catheter Ablation, Direct Oral Anticoagulant, Direct Oral Anticoagulant Edoxaban, Non-Vitamin K Oral Anticoagulants, Periprocedural,
• MeSH
• antikoagulancia aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• cévní mozková příhoda diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• fibrilace síní komplikace   mortalita   patofyziologie   chirurgie   MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• ischemie mozku diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• katetrizační ablace * škodlivé účinky   mortalita   MeSH
• klinické protokoly MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• prospektivní studie MeSH
• pyridiny aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory MeSH
• rozvrh dávkování léků MeSH
• thiazoly aplikace a dávkování   škodlivé účinky   MeSH
• vitamin K antagonisté a inhibitory   MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• warfarin aplikace a dávkování   škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antikoagulancia MeSH
• edoxaban MeSH Prohlížeč
• inhibitory faktoru Xa MeSH
• pyridiny MeSH
• thiazoly MeSH
• vitamin K MeSH
• warfarin MeSH

AIMS: This study aimed to compare the efficacy and safety of heparin and nadroparin in order to provide an additional therapeutic option for patients with acute ischemic stroke in, whom systemic thrombolysis was excluded, or thrombectomy could not be performed. METHODS: We describe a prospective randomized double-blind placebo-controlled pilot study in acute ischemic stroke. The therapeutic window was between 4.5 and 24 h after the onset of stroke. During the first 24 h of treatment, the patients divided into 3 groups received placebo, heparin or nadroparin (in therapeutic doses). During the following 48 h, each patient received nadroparin in the therapeutic dose. 24 h after start of treatment they began taking 100 mg aspirin daily. The primary safety indicator was incidence of complications such as intracerebral or systemic hemorrhage, or death. Efficacy was primarily monitored by the neurological modified Rankin Scale (mRS) at 90 days. RESULTS: There were no signs of intracerebral or systemic bleeding in the cohort of 87 patients. Two patients died - one (3.7%) in the heparin and one (3.8%) in the placebo group due to causes not connected with the treatment. There was a statistically significant difference in mRS on the 90th day between the heparin and placebo groups (21 (80%) vs 13 (50%), P=0.0350) and between the nadroparin and placebo groups (29 (85%) vs 13 (50%), P=0.0031). CONCLUSION: The results show that the treatment with heparin and nadroparin is safe and effective. TRIAL REGISTRATION: Trial is registered in ClinicalTrials.gov: NCT01862978.

• Klíčová slova
• Key words: acute ischemic stroke, efficacy, heparin, mRS, nadroparin, safety,
• MeSH
• antikoagulancia aplikace a dávkování   škodlivé účinky   MeSH
• aplikace kožní MeSH
• cévní mozková příhoda prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• heparin nízkomolekulární aplikace a dávkování   škodlivé účinky   MeSH
• heparin aplikace a dávkování   škodlivé účinky   MeSH
• intravenózní infuze MeSH
• ischemie mozku prevence a kontrola   MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• nadroparin aplikace a dávkování   škodlivé účinky   MeSH
• pilotní projekty MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antikoagulancia MeSH
• heparin nízkomolekulární MeSH
• heparin MeSH
• nadroparin MeSH