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In patients treated with dual aspirin/clopidogrel therapy, nuisance and internal bleeding were significantly associated with template BT and with IPAmax in response to ADP 2 μmol/L but not in response to ADP 4 μmol/L or 8 μmol/L.
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Thromboembolic events, primarily stroke, might complicate transcatheter aortic-valve implantation (TAVI) procedures in 3-5 % of cases. Thus, it is common to administer aspirin and clopidogrel pharmacotherapy for 3-6 months following TAVI in order to prevent those events. The biologic response to the dual anti platelet treatment (DAPT) is heterogeneous, e.g. low response, known as high on treatment platelet reactivity (HTPR) may be associated with adverse thromboembolic events. Little is known about the prevalence of HTPR among patients undergoing TAVI. To assess the variability in response and rates of residual platelet reactivity in patients undergoing TAVI. We examined platelet reactivity in response to clopidogrel and aspirin in 40 consecutive patients (mean age 81.7 ± 6.5 years, 66.7 % women) who underwent successful TAVI using the VerifyNow P2Y12 assay and the multiple electrode aggregometry assay (Multiplate analyzer) in response to adenosine diphosphate and arachidonic acid respectively, at different time points before and following TAVI. Before TAVI, the majority of patients were on antiplatelet therapy (68.5 % aspirin, 12.5 % clopidogrel, 12.5 % DAPT). Following the procedure all patients were on DAPT or clopidogrel and warfarin. Among analyzed patients, 41 % had HTPR for clopidogrel and 12.5 % for aspirin at baseline, which did not significantly change 1-month following the procedure (p = 0.81 and p = 0.33, respectively). In conclusion, patients undergoing TAVI for severe aortic stenosis and treated with DAPT have high rates of residual platelet reactivity during the peri-procedural period and up to 1-month thereafter. These findings may have clinical implications for the anti-platelet management of TAVI patients.
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Longterm followup of BCI demonstrates that antithrombotic therapy prevents cerebral infarction; antiplatelet therapy and anticoagulation are equally effective; and carotid stents appear to be safe and effective for lesions that develop pseudoaneurysms or extensive dissections.
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It is known that hepatic metabolism limits the antiaggregatory activity of clopidogrel and, as a consequence, its clinical benefits. In this study, we investigated whether other factors exist that could account for clopidogrel's suboptimal antithrombotic activity. Using an in vivo murine FeCl(3) thrombosis model coupled with intravital microscopy, we found that at equivalent, maximal levels of inhibition of ADP-induced platelet aggregation, clopidogrel (50 mg/kg p.o.) failed to reproduce the phenotype associated with P2Y(12) deficiency. However, elinogrel (60 mg/kg p.o.), a direct-acting reversible P2Y(12) antagonist, achieved maximal levels of inhibition in vivo, and its administration (1 mg/kg i.v.) abolished residual thrombosis associated with clopidogrel dosing. Because elinogrel is constantly present in the plasma, whereas the active metabolite of clopidogrel exists for ∼2 h, we evaluated whether an intracellular pool of P2Y(12) exists that would be inaccessible to clopidogrel and contribute to its limited antithrombotic activity. Using saturation [(3)H]2-(methylthio)ADP ([(3)H]2MeSADP) binding studies, we first demonstrated that platelet stimulation with thrombin and convulxin (mouse) and thrombin receptor activating peptide (TRAP) (human) significantly increased surface expression of P2Y(12) relative to that of resting platelets. We next found that clopidogrel dose-dependently inhibited ADP-induced aggregation, signaling (cAMP), and surface P2Y(12) on resting mouse platelets, achieving complete inhibition at the highest dose (50 mg/kg), but failed to block this inducible pool. Thus, an inducible pool of P2Y(12) exists on platelets that can be exposed upon platelet activation by strong agonists. This inducible pool is not blocked completely by clopidogrel, contributes to thrombosis in vivo, and can be blocked by elinogrel.
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To evaluate the safety of low-dose aspirin plus clopidogrel versus high-dose aspirin plus clopidogrel in prevention of vascular risk within 90 days of duration of dual antiplatelet therapy in patients treated with intracranial endovascular treatment.
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Bioresorbable scaffolds are increasingly used in patients with coronary artery disease undergoing percutaneous coronary interventions. ABSORB EXTEND is an ongoing study that will recruit 800 patients. This report evaluates acute and late scaffold failure in the first 450 patients enrolled in ABSORB EXTEND who have completed 12 months follow-up.
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A decision-tree model consisting of five health states (myocardial infarction, stroke, bleeding, stent thrombosis and cardiovascular death) was developed. Clinical outcome data (two TRITON-TIMI 38 genetic sub-studies) comparing clopidogrel and prasugrel for both *2 allele carriers and non-carriers were combined with the prevalence of the heterozygosity for the *2 allele in New Zealand Europeans (15%), Maoris (24%), Asians (29%) and Pacific Islanders (45%) to determine the predicted adverse event rate for the New Zealand population. National hospital diagnosis-related group (DRG) discharge codes were used to determine alternative adverse event rates, along with the costs of hospitalizations during the 15 months after patients presented with an ACS. The primary outcome measure was the incremental cost per QALY (calculated using literature-reported weights). Monte Carlo simulations and alternative scenario analysis based on both clinical trial and national hospital incidence were used. Additional analysis considered the overall TRITON-TIMI 38 rates. Costs (in New Zealand dollars [$NZ], year 2009 values) and benefits were discounted at 3% per annum.
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Ticagrelor vs. clopidogrel post-ACS was associated with a lower risk of death, MI, or stroke, as well as death alone. Risk of bleeding was higher with ticagrelor. These real-world outcomes are consistent with randomized trial results.
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In a novel application, we prospectively monitored ischemic, bleeding, and mortality outcomes among patients initiating prasugrel versus clopidogrel in routine care during the first 2 years following the approval of prasugrel.
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After coronary stent implantation, patients with acute coronary syndrome commonly take clopidogrel, and few patients develop severe thrombocytopenia related to clopidogrel. However, we found in our clinical practice that platelet counts of most patients decrease slightly after taking clopidogrel for 6 months. To address this discrepancy, we studied the change in platelet count after coronary stent implantation in patients with acute coronary syndrome. Ninety-five patients were selected for this study, and their pre-stent platelet counts were compared with those 6 months after stent implantation. All patients had low/intermediate-risk non-ST segment elevation myocardial infarction/unstable angina and underwent delayed coronary interventional treatment. No patient suffered from thrombocytopenia (<100 × 10/l) during the 6-month observation period. Six months after stent implantation, platelet counts significantly decreased in the majority of patients (73/95, 76.9%) and increased only in the minority of patients (22/95, 23.1%). A multivariate analysis showed that the change in platelet count was positively correlated with the change in leukocyte and fibrinogen value, and negatively correlated with number of stents. The platelet count decreased in the majority of patients after stent implantation, which may be caused by the removal of stress factors or stent-related platelet consumption. Clopidogrel may partly prevent stent-related platelet consumption.
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Atrial fibrillation (AF) is the most potent common risk factor for ischemic stroke. The number of Americans with nonvalvular AF is expected to increase markedly over the next several decades, making AF-related stroke an important public health concern. Given the individual and societal burden associated with AF-related stroke, efforts to identify and implement efficacious and acceptably safe therapeutic stroke prevention strategies are paramount. This article reviews the existing randomized trial evidence supporting the efficacy of oral vitamin K antagonists (ie, warfarin) or aspirin for preventing thromboembolism in AF, as well as completed and ongoing studies exploring novel antithrombotic agents including the oral direct thrombin inhibitor, ximelagatran, other antiplatelet agents (eg, clopidogrel), factor Xa inhibitors, and other pharmacological agents and additional therapeutic approaches such as mechanical devices and surgical procedures to obliterate the left atrial appendage.
In this double-blind, placebo-controlled study, we randomly assigned 5362 patients who had not been treated with clopidogrel to receive either cangrelor or placebo at the time of PCI, followed by 600 mg of clopidogrel. The primary end point was a composite of death, myocardial infarction, or ischemia-driven revascularization at 48 hours. Enrollment was stopped when an interim analysis concluded that the trial would be unlikely to show superiority for the primary end point.
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Atrial fibrillation (AF) is a major cause of stroke and thromboembolism, resulting in substantial morbidity and mortality. For the majority of patients with AF, aspirin has a limited role in stroke prevention, being an inferior strategy and not necessarily safer than the anticoagulant warfarin, especially in the elderly. Novel oral anticoagulant drugs, such as oral direct thrombin inhibitors and oral factor Xa inhibitors, might further diminish the role of aspirin for stroke prevention in AF. Nonetheless, aspirin use should continue in the early stages following presentation of a patient with AF and acute coronary syndrome, and after stenting, in combination with oral anticoagulant drugs and clopidogrel, as appropriate. Notably, aspirin combined with clopidogrel shows only modest benefit in stroke prevention compared with aspirin monotherapy in patients with AF who refuse oral anticoagulant drugs (including warfarin), or in those individuals who have difficulties in anticoagulation monitoring, and can be used where bleeding risk is not excessive.
Rattlesnake envenomations commonly produce coagulopathy and thrombocytopenia, yet clinically significant bleeding is uncommon. It is unknown if patients who use antiplatelet or anticoagulant medications prior to envenomation are at increased risk for bleeding after envenomation.
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Acute coronary syndrome (ACS) is a fatal cardiovascular disease caused by atherosclerotic plaque erosion or rupture and formation of coronary thrombus. The latest guidelines for ACS recommend the combined drug regimen, comprising aspirin, P2Y12 inhibitor, angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, β-blocker, and statin, at discharge after ACS treatment to reduce recurrent ischemic cardiovascular events. This study aimed to examine prescription patterns of secondary prevention drugs in Korean patients with ACS after hospital discharge, to access the appropriateness of secondary prevention drug therapy for ACS, and to evaluate whether to persistently use discharge medications for 18 months.
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The study group included 42 patients undergoing elective coronary angiography and percutaneous coronary intervention. The plasma concentrations of CLP and its metabolites were measured by a validated HPLC-MS/MS method. Whole-blood aggregation was determined with Multiplate analyzer. For evaluation of ABCB1 3435C>T polymorphism, PCR-RFLP method was applied.
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Individual susceptibility to environmental, chemical, and drug toxicity is to some extent determined by polymorphism in drug-metabolizing enzymes, in particular the cytochromes P450 (CYPs). This polymorphism is in particular translated into risk differences concerning drugs metabolized by the highly polymorphic enzymes CYP2C9, CYP2C19, and CYP2D6, whereas CYP enzymes active in procarcinogen activation are relatively well conserved without important functional polymorphisms. Examples of drug toxicities that can be predicted by P450 polymorphism include those exerted by codeine, tramadol, warfarin, acenocoumarol, and clopidogrel. The polymorphic CYP2A6 has a role in nicotine metabolism and smoking behavior. Besides this genetic variation, genome-wide association studies now allow for the identification of an increasing number of predictive genetic biomarkers among, e.g., human leukocyte antigens and to some extent drug transporters that provide useful information regarding the choice of the drug and drug dosage in order to avoid toxicity. The translation of this information into the clinical practice has been slow; however, an increasing number of pharmacogenomic drug labels are assigned, where the predictive genotyping before drug treatment can be mandatory, recommended, or only for informational purposes. In this review, we provide an update of the field with emphasis on CYP polymorphism.
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Poor response to clopidogrel is an independent predictor of periprocedural myocardial infarction and worse 1-year outcome in low-risk patients undergoing PCI, whereas poor response to aspirin failed to predict a worse outcome. Contrary to what was observed in poor responders, glycoprotein IIb/IIa inhibitor therapy failed to provide a benefit in aspirin and/or clopidogrel full responders.
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Stroke is the second leading cause of cardiovascular mortality in the modern world, accounting for 80% of strokes of ischemic origin. There are two main etiologies of ischemic stroke: 70% to 80% are caused by carotid atherosclerotic plaque rupture and superimposed thrombus formation, whereas 30% are caused by systemic embolism of a cardiac thrombus (mainly in atrial fibrillation [AF] patients). Therefore, antithrombotic therapy is the cornerstone of stroke treatment. In AF patients, thrombotic risk should be assessed by means of the CHADS2 score. Patients with a score of 0 should be treated with aspirin; for those with a score of 1, oral anticoagulation (target international normalized ratio, 2-3) or aspirin is recommended. For patients with a CHADS2 score ≥2, oral anticoagulation with warfarin should be initiated (unless contraindicated). If warfarin is contraindicated, antithrombotic treatment should be prescribed (the combination of aspirin and clopidogrel seems to be superior to aspirin alone). For primary prevention in atherosclerotic patients, low-dose aspirin is useful only in women older than 45 years who are not at risk for intracranial hemorrhage and do not have gastrointestinal intolerance (a very small but significant effect). For secondary prevention in atherosclerotic patients, antithrombotic therapy should be administered. It is recommended that patients who do not require anticoagulation receive clopidogrel or a combination of aspirin and dipyridamole. Alternatively, aspirin alone or triflusal may be used. Within 4.5 h of onset of acute stroke, thrombolytic therapy (recombinant tissue plasminogen activator) must be injected urgently (unless contraindicated). Dabigatran is a new oral anticoagulant (competitive thrombin inhibitor) with a promising role in stroke prevention; at low doses, it is noninferior to warfarin for stroke prevention and is safer, whereas at high doses, it is superior to warfarin in stroke prevention with the same incidence of bleeding. Percutaneous left atrial appendage occluders recently were approved for systemic embolism prevention. The use of warfarin after implantation is still under discussion. Dronedarone, a new antiarrhythmic agent, has been shown to decrease cardiovascular mortality and stroke in patients with AF. Carotid endarterectomy surgery is indicated in symptomatic patients with stenosis greater than 70% and in selected patients with 50% to 70% stenosis. Currently, carotid endarterectomy surgery is superior to carotid angioplasty and stenting.
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The majority of high-grade blunt VA injuries remain stable or are improved at final follow-up. Despite a 4% rate of radiographic worsening in the Grade 3 blunt VA injury group and a 35% recanalization rate in the Grade 4 blunt VA injury group, there were no adverse clinical outcomes associated with these radiographic changes. No cerebral infarctions were noted in the Grade 3 group. A 7% stroke rate was identified in the Grade 4 blunt VA injury group; however, this was confined to the immediate postinjury period and was associated with 100% mortality. While these data suggest that these high-grade vertebral artery injuries may require less intensive radiographic follow-up, future prospective studies are needed to make conclusive changes related to treatment and management.
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Dual antiplatelet therapy (DAT) with clopidogrel plus aspirin is a well-established antithrombotic strategy, with hemorrhage being the chief adverse event (AE) of concern. Outside of clinical trials, few published data describe the magnitude and nature of hemorrhage-related AEs from DAT.
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In a real-world PCI population, the combination of PPIs and clopidogrel was associated with a doubling of MI rates after 3 years. Even after correction for confounding factors, concomitant PPI use remained an independent predictor of outcome emphasizing the clinical importance of this drug-drug interaction.