scholarly journals Study of Pharmacodynamic and Pharmacokinetic Interaction of Bojungikki-Tang with Aspirin in Healthy Subjects and Ischemic Stroke Patients

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Jung-Hwa Yoo ◽  
Sung-Vin Yim ◽  
Byung-Cheol Lee
Keyword(s):  
Salicylic Acid ◽  
Ischemic Stroke ◽  
Platelet Aggregation ◽  
Healthy Subjects ◽  
Pharmacokinetic Interaction ◽  
Phase Iii ◽  
Stroke Patients ◽  
Open Label ◽  
Male Subjects ◽  
Curve Maximum

Background. Bojungikki-tang (BJIKT) is a widely used traditional herbal formula in China, Japan, and Korea. There have been reports that several herbs among BJIKT have interactions with antiplatelet drugs, such as aspirin. This study aimed to assess whether BJIKT interacts with aspirin in terms of pharmacokinetics (PK) and pharmacodynamics (PD) in healthy subjects and ischemic stroke patients. Methods. The phase I interaction trial was a randomized, open-label, crossover study of 10 healthy male subjects, and the phase III interaction trial was a randomized, placebo-controlled, parallel study of 43 ischemic stroke patients. Each participant randomly received aspirin + BJIKT or aspirin + placebo. For PK analysis, plasma acetyl salicylic acid (ASA) and salicylic acid (SA) were evaluated, and, for PD analysis, platelet aggregation and plasma thromboxane B2 (TxB2) were measured. Results. In the PK parameters, mean area under curve, maximum concertation, and peak concentration time of ASA and SA were not different between two groups in healthy subjects and ischemic stroke patients. In the PD profiles, TxB2 concentrations and platelet aggregation were not affected by coadministration of BJIKT in healthy subjects and ischemic stroke patients. Conclusions. These results suggest that coadministration of BJIKT with aspirin may not result in herb-drug interaction.

Abstract 183: Time to Alteplase and Symptomatic Intracranial Hemorrhage Complication Rates

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Muhammad U Farooq ◽  
Kathie Thomas
Keyword(s):  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
American Heart ◽  
Phase Iii ◽  
P Value ◽  
Complication Rates ◽  
Stroke Patients ◽  
Number Of Patients ◽  
Symptomatic Intracranial Hemorrhage ◽  
Get With The Guidelines

Background/Objective: The American Heart Association’s Target Stroke initiative focuses on reducing door-to-needle time for faster treatment with Alteplase and improved patient outcomes. The concern for reducing door-to-needle time is that there will be an increase in complication rates, specifically the rate of symptomatic intracranial hemorrhage (ICH). This study sought to review whether reduced door-to-needle times were associated with increased rates of complications in Midwest hospitals. Methods: A retrospective review of acute ischemic stroke patients treated with Alteplase was conducted from 2010-2018 in 13 Midwestern states (IN, IL, KS, KY, MI, MN, NO, ND, OH, SD, and WI) using the American Stroke Association’s Get With The Guidelines (GWTG) Stroke database. Percentage of eligible patients treated with Alteplase, treatment times, and complication rates were reviewed. Results: From 2010-2018 the rate of ischemic stroke patients treated with Alteplase in the approved 3-hour window increased from 68.9% to 88.5%. The number of patients treated with Alteplase in 60 minutes increased from 24.1% in 2010 to 74.9% in 2018. The median time to treatment for Alteplase was reduced from 80 minutes in 2010 to 46 minutes in 2018. The rate of complications associated with thrombolytics was 6.5% in 2010 and dropped to 4.5% in 2018. This is statistically significant at a p-value of .05. Conclusions: In the Midwest Region, a reduction in door-to-needle times was not associated with increased complication rates. Interestingly, a reduction in door-to-needle times was associated with a reduction in complication rates. This supports the American Heart Association’s new Target Stroke Phase III initiative which seeks to further reduce door-to-needle times.

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study

Vaccine ◽  
2020 ◽  
Vol 38 (22) ◽  
pp. 3839-3846
Author(s):  
Chia-Yuan Chang ◽  
Ching-Yi Cho ◽  
Chou-Cheng Lai ◽  
Chun-Yi Lu ◽  
Luan-Yin Chang ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Healthy Subjects ◽  
Phase Iii ◽  
Open Label

scholarly journals Abnormal EEG Complexity and Functional Connectivity of Brain in Patients with Acute Thalamic Ischemic Stroke

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Shuang Liu ◽  
Jie Guo ◽  
Jiayuan Meng ◽  
Zhijun Wang ◽  
Yang Yao ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Functional Connectivity ◽  
Healthy Subjects ◽  
Brain Network ◽  
Control Group ◽  
Stroke Patients ◽  
Cerebral Disease ◽  
Essential Information ◽  
Stroke Group ◽  
The Brain

Ischemic thalamus stroke has become a serious cardiovascular and cerebral disease in recent years. To date the existing researches mostly concentrated on the power spectral density (PSD) in several frequency bands. In this paper, we investigated the nonlinear features of EEG and brain functional connectivity in patients with acute thalamic ischemic stroke and healthy subjects. Electroencephalography (EEG) in resting condition with eyes closed was recorded for 12 stroke patients and 11 healthy subjects as control group. Lempel-Ziv complexity (LZC), Sample Entropy (SampEn), and brain network using partial directed coherence (PDC) were calculated for feature extraction. Results showed that patients had increased mean LZC and SampEn than the controls, which implied the stroke group has higher EEG complexity. For the brain network, the stroke group displayed a trend of weaker cortical connectivity, which suggests a functional impairment of information transmission in cortical connections in stroke patients. These findings suggest that nonlinear analysis and brain network could provide essential information for better understanding the brain dysfunction in the stroke and assisting monitoring or prognostication of stroke evolution.

scholarly journals Co-Administration of Vonoprazan, Not Tegoprazan, Affects the Pharmacokinetics of Atorvastatin in Healthy Male Subjects

2021 ◽  
Vol 12 ◽  
Author(s):  
Sejung Hwang ◽  
Jae-Wook Ko ◽  
Heechan Lee ◽  
Seokuee Kim ◽  
Bongtae Kim ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Clinical Laboratory ◽  
Systemic Exposure ◽  
Cytochrome P450 3A4 ◽  
Healthy Male ◽  
Open Label ◽  
Once Daily ◽  
New Class ◽  
Inhibitory Activities ◽  
Male Subjects

Potassium-competitive acid blocker is a new class of drugs inhibiting gastric acid. It is controversial that vonoprazan showed the inhibitory activities of cytochrome P450 3A4. This study aimed to evaluate the pharmacokinetics (PK) of atorvastatin and safety when atorvastatin was administered alone and co-administered with vonoprazan or tegoprazan. An open-label, multiple-dose, 3-intervention, 4-sequence, 4-period, partial replicate crossover study was conducted, and three interventions were; one is orally administered atorvastatin 40 mg alone once daily for 7 days, another is atorvastatin co-administered with vonoprazan 20 mg, and the other is atorvastatin co-administered with tegoprazan 50 mg. PK blood samples were collected up to 24 h after the last dose, and PK parameters for atorvastatin, 2-hydroxyatorvastatin and atorvastatin lactone were estimated by a non-compartmental method. Safety was evaluated, including adverse events and clinical laboratory tests. A total of 28 subjects completed the study. When atorvastatin was co-administered with vonoprazan, the systemic exposures of atorvastatin and atorvastatin lactone significantly increased, and the metabolic ratio of 2-hydroxyatorvastatin significantly decreased. Hypergastrinemia only occurred when atorvastatin was co-administered with vonoprazan. However, the plasma concentration profiles of atorvastatin, 2-hydroxyatorvastatin and atorvastatin lactone were similar when atorvastatin was administered alone or co-administered with tegoprazan. In conclusion, after multiple doses of atorvastatin co-administered with vonoprazan in healthy subjects, the systemic exposure of atorvastatin and the incidence of hypergastrinemia increased. With tegoprazan, however, those interactions were not observed.

Effects of IgG from the serum of ischemic stroke patients on hemostasis

2021 ◽  
Author(s):  
Tetiana Katrii ◽  
Nataliia Raksha ◽  
Tetiana Halenova ◽  
Tetiana Vovk ◽  
Olga Kravchenko ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Healthy Subjects ◽  
Protein A ◽  
Factor Xa ◽  
Modern Medicine ◽  
First Year ◽  
Thrombin Time ◽  
Stroke Patients ◽  
One Year ◽  
Hemostasis Factors

Ischemic stroke is among the top diseases leading to mortality and disability in the world. The detailed investigation of the mechanisms underlying this pathology and especially mediating the tendency to relapse during the first year after stroke incident undoubtedly belongs to important tasks of modern medicine and biology. The current study aims to analyze the influence of IgG derived from the blood serum of ischemic stroke patients on some hemostasis factors. In total, 123 participants with IS, 62 with atherothrombotic ischemic stroke, 61 with cardioembolic ischemic stroke, and 57 subjects as control have been examined. The same patients have participated in the research a year after stroke. IgG from serum was isolated by affinity chromatography on protein A Sepharose column. The activity of key hemostasis factors under the influence of IgG was analyzed. Obtained results revealed that IgG of stroke patients but not healthy subjects caused the inhibition of the amidolytic activity of endogenously generated thrombin, protein C, factor Xa, and led to an increase in the degree of ADP-induced platelet aggregation. The reduction of clotting time in the test "Thrombin time" by IgG of patients at the acute phase of disease was also observed; IgG of healthy subjects mediated the opposite effect. In contrast to acute ischemic stroke IgG, IgG of patients one year after both atherothrombotic and cardioembolic ischemic stroke influenced only the activity of endogenously generated thrombin and factor Xa resulting in inhibition of their activities. It was also established that IgG of ischemic stroke patients, as well as healthy subjects, stimulated the secretion of tissue plasminogen activator by endotheliocytes.

scholarly journals Pharmacokinetic Interaction between Maraviroc and Fosamprenavir-Ritonavir: an Open-Label, Fixed-Sequence Study in Healthy Subjects

2013 ◽  
Vol 57 (12) ◽  
pp. 6158-6164 ◽  
Author(s):  
Manoli Vourvahis ◽  
Anna Plotka ◽  
Laure Mendes da Costa ◽  
Annie Fang ◽  
Jayvant Heera
Keyword(s):  
Healthy Subjects ◽  
Geometric Mean ◽  
Active Form ◽  
Pharmacokinetic Interaction ◽  
Pharmacokinetic Parameters ◽  
Maximum Plasma ◽  
Open Label ◽  
Fixed Sequence ◽  
Dosing Interval ◽  
Period 2

ABSTRACTThis open-label, fixed-sequence, phase 1 study evaluated the pharmacokinetic interaction between maraviroc (MVC) and ritonavir-boosted fosamprenavir (FPV/r) in healthy subjects. In period 1, subjects received 300 mg of MVC twice daily (BID; cohort 1) or once daily (QD; cohort 2) for 5 days. In period 2, cohort 1 subjects received 700/100 mg of FPV/r BID alone on days 1 to 10 and then FPV/r at 700/100 mg BID plus MVC at 300 mg BID on days 11 to 20; cohort 2 subjects received FPV/r at 1,400/100 mg QD alone on days 1 to 10 and then FPV/r at 1,400/100 mg QD plus MVC at 300 mg QD on days 11 to 20. Pharmacokinetic parameters, assessed on day 5 of period 1 and on days 10 and 20 of period 2, included the maximum plasma concentration (Cmax), the concentration at end of dosing interval (Cτ), and the area under the curve over dosing interval (AUCτ). Safety and tolerability were also assessed. MVC geometric mean AUCτ,Cmax, andCτwere increased by 149, 52, and 374%, respectively, after BID dosing with FPV/r, and by 126, 45, and 80%, respectively, after QD dosing. Amprenavir (the active form of the prodrug fosamprenavir) and ritonavir exposures were decreased in the presence of MVC with amprenavir AUCτ,Cmax, andCτdecreased by 34 to 36% in the presence of FPV/r plus maraviroc BID and by 15 to 30% with FPV/r plus MVC QD both compared to FPV/r alone. The overall all-causality adverse-event (AE) incidence rate was 96.4%; all AEs were of mild or moderate severity. Commonly reported treatment-related AEs (>20% of patients overall) included diarrhea, fatigue, abdominal discomfort, headache, and nausea. No serious AEs or deaths occurred. In summary, maraviroc exposure increased in the presence of FPV/r, whereas MVC coadministration decreased amprenavir and ritonavir exposures. MVC dosed at 300 mg BID with FPV/r is not recommended due to concerns of lower amprenavir exposures; however, no dose adjustment is warranted with MVC at 150 mg BID in combination with FPV/r based on the available clinical data. MVC plus FPV/r was generally well tolerated; no new safety signals were detected.

scholarly journals Frequency of Aspirin Resistance in Ischemic Stroke Patients and Healthy Controls from Colombia

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Alejandro Roman-Gonzalez ◽  
Carlos Andrés Naranjo ◽  
Walter D. Cardona-Maya ◽  
Dionis Vallejo ◽  
Francisco Garcia ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Platelet Aggregation ◽  
Univariate Analysis ◽  
Aspirin Resistance ◽  
Aspirin Therapy ◽  
Stroke Recurrence ◽  
Healthy Controls ◽  
Test Results ◽  
Stroke Patients ◽  
Ischemic Cerebrovascular Disease

Objective. To evaluate the aspirin resistance prevalence in patients with previous ischemic cerebrovascular disease undergoing aspirin therapy for secondary prevention. Materials and Methods. Three hundred fifty patients presenting ischemic strokes and 100 healthy controls under aspirin treatment were evaluated using the optic platelet aggregation test. Results. Aspirin resistance was found in 7.4% of the patients with ischemic stroke and 4% of controls. Aspirin resistance was associated with stroke recurrence in univariate analysis ( p = 0.004 ). Aspirin resistance was not associated with smoking, diabetes, or hypercholesterolemia. Conclusion. Aspirin resistance is present in Colombian patients with ischemic stroke as well as in healthy controls.

Abstract 59: Extending the Time for Thombolysis in Emergency Neurological Deficits (EXTEND) - High Prevalence of Intracranial Vessel Occlusion in Wake-up-stroke Patients

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Henry Ma ◽  
Bruce C Campbell ◽  
Mark W Parsons ◽  
Christopher Levi ◽  
Atte Meretoja ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Cerebral Artery ◽  
Stroke Onset ◽  
Phase Iii ◽  
Neurological Deficits ◽  
Lesion Volume ◽  
Stroke Patients ◽  
Vessel Occlusion ◽  
Intracranial Vessel ◽  
Ct Angiogram

Background: EXTEND is an investigator-initiated, randomised, double-blind and placebo-controlled Phase III trial of intravenous alteplase vs placebo in patients with ischemic stroke 4.5-9 hours from stroke onset or wake-up-stroke (WUS). The prevalence of intra-cranial vessel occlusion in WUS patients remains to be determined and can guide the development of optimal therapy for this unique group of stroke patients. Objective: To study the prevalence and characteristics of intra-cranial vessel occlusion in this WUS cohort. Methods: Ischemic stroke patients within 4.5-9 hours from stroke onset or with WUS (time of WUS onset defined as the midpoint between time to sleep and awakening with the stroke symptoms) are eligible for enrollment. Criteria for entry into the trial include perfusion-diffusion mismatch using a perfusion threshold of Tmax>6sec and a perfusion:diffusion lesion volume ratio of >1.2. Diffusion lesion volume must be <70mL based on assessment by automated RAPID software. Intra-cranial vessel occlusion was assessed on MR or CT angiogram performed at randomisation and 24 later. Two expert readers assessed these images independently. Results: 97 patients had images with adequate quality, including 63 (65%) in the WUS group with median age of 77.0 yrs (IQR 67.0, 81.0) and NIHSS of 14.0 (9.0, 19.0). 62 of 63 patients (98%) had vessel occlusion with 44.4% involving M1 of the middle cerebral artery, 17.5% M2, 4.8% M3, 25.4% both internal carotid artery (ICA) and M1, 4.8% ICA alone and 3.1% the posterior cerebral artery. The median ischemic core volume was 15.0 ml (6.5, 31.5), Tmax>6 volume 88.5ml (58.0, 122.0), mismatch volume 65.5ml (42.8, 92.0), and ratio of 4.8 (2.5, 8.7). 19 patients (30%) demonstrated recanalization on follow-up imaging. Conclusion: In WUS patients there is a very high rate of intracranial vessel occlusion with relatively large volumes of salvageable penumbral tissue. Intravenous thrombolytic therapy followed by thrombectomy in selected cases may be an appropriate therapeutic option with safety and efficacy remaining to be established in randomized controlled trials.

Sign in / Sign up

Export Citation Format

Share Document