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A Randomised Controlled Trial of Triple Antiplatelet Therapy (Aspirin, Clopidogrel and Dipyridamole) in the Secondary Prevention of Stroke: Safety, Tolerability and Feasibility  [PDF]
Nikola Sprigg, Laura J. Gray, Tim England, Mark R. Willmot, Lian Zhao, Gillian M. Sare, Philip M. W. Bath
PLOS ONE , 2008, DOI: 10.1371/journal.pone.0002852
Abstract: Background Aspirin, dipyridamole and clopidogrel are effective in secondary vascular prevention. Combination therapy with three antiplatelet agents might maximise the benefit of antiplatelet treatment in the secondary prevention of ischaemic stroke. Methodology/Principal Findings A randomised, parallel group, observer-blinded phase II trial compared the combination of aspirin, clopidogrel and dipyridamole with aspirin alone. Adult patients with ischaemic stroke or transient ischaemic attack (TIA) within 5 years were included. The primary outcome was tolerability to treatment assessed as the number of patients completing randomised treatment. Recruitment was halted prematurely after publication of the ESPRIT trial (which confirmed that combined aspirin and dipyridamole is more effective than aspirin alone). 17 patients were enrolled: male 12 (71%), mean age 62 (SD 13) years, lacunar stroke syndrome 12 (71%), median stroke/TIA onset to randomisation 8 months. Treatment was discontinued in 4 of 9 (44%) patients receiving triple therapy vs. none of 8 taking aspirin (p = 0.08). One recurrent stroke occurred in a patient in the triple group who was noncompliant of all antiplatelet medications. The number of patients with adverse events and bleeding complications, and their severity, were significantly greater in the triple therapy group (p<0.01). Conclusions/Significance Long term triple antiplatelet therapy was asociated with a significant increase in adverse events and bleeding rates, and their severity, and a trend to increased discontinuations. However, the patients had a low risk of recurrence and future trials should focus on short term therapy in high risk patients characterised by a very recent event or failure of dual antiplatelet therapy. Trial Registration Controlled-Trials.com ISRCTN83673558
Nadroparin plus aspirin versus aspirin alone in the treatment of acute ischemic stroke  [cached]
Sarma G,Roy A
Neurology India , 2003,
Abstract: Low-molecular-weight-heparin (LMWH) has been widely used in the treatment of acute ischemic stroke but controlled trials are few. In this study, 40 patients with acute ischemic stroke of less than 24 hours duration were randomized to receive either aspirin (325 mg/day) alone or aspirin (325 mg/day) plus subcutaneous nadroparin 4100 units/day. At the end of 4 weeks, the morbidity and mortality were significantly less in the nadroparin group as compared to the aspirin group. There was no increased risk of clinically significant intracranial hemorrhage in either group. The combination of aspirin and LMWH deserves to be tested in larger studies.
The Efficacy and Adverse Reaction of Bleeding of Clopidogrel plus Aspirin as Compared to Aspirin Alone after Stroke or TIA: A Systematic Review  [PDF]
Yan Huang, Man Li, Jian-Yong Li, Min Li, Yuan-Peng Xia, Ling Mao, Bo Hu
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0065754
Abstract: Background and Purpose Given the high risk of stroke after TIA (transient ischemia attack) or stroke and the adverse reaction of bleeding of antiplatelets, we undertook a meta-analysis, reviewed randomized controlled trials (RCTs) comparing aspirin plus clopidogrel with aspirin alone to determine the efficacy and adverse reaction of bleeding of the two protocols in the prevention of stroke. Methods We analyzed the incidences of stroke, bleeding and severe bleeding by using fixed-effect model or random-effect model on the basis of the result of heterogeneity test. Results Five qualified RCTs satisfied the inclusion criteria. We found that treatment with aspirin plus clopidogrel was associated with lower incidence of stroke (Risk Ratio (RR), 0.66, 95% confidence interval (CI), 0.47 to 0.93), higher incidence of bleeding (RR, 1.75, 95% CI, 1.48 to 2.05) as compared with aspirin-alone treatment. In terms of severe bleeding, no statistical difference existed between them (RR, 2.21, 95% CI, 0.25 to 19.52). Conclusion The combined use of aspirin and clopidogrel is more effective than aspirin alone for patients with previous TIA or stroke for the prevention of stroke, with risk of bleeding being higher. No statistical difference was found in severe bleeding between the two treatment protocols.
Clinical importance of aspirin and clopidogrel resistance  [cached]
Gergely Feher,Andrea Feher,Gabriella Pusch,Katalin Koltai
World Journal of Cardiology , 2010,
Abstract: Aspirin and clopidogrel are important components of medical therapy for patients with acute coronary syndromes, for those who received coronary artery stents and in the secondary prevention of ischaemic stroke. Despite their use, a significant number of patients experience recurrent adverse ischaemic events. Interindividual variability of platelet aggregation in response to these antiplatelet agents may be an explanation for some of these recurrent events, and small trials have linked “aspirin and/or clopidogrel resistance”, as measured by platelet function tests, to adverse events. We systematically reviewed all available evidence on the prevalence of aspirin/clopidogrel resistance, their possible risk factors and their association with clinical outcomes. We also identified articles showing possible treatments. After analyzing the data on different laboratory methods, we found that aspirin/clopidogrel resistance seems to be associated with poor clinical outcomes and there is currently no standardized or widely accepted definition of clopidogrel resistance. Therefore, we conclude that specific treatment recommendations are not established for patients who exhibit high platelet reactivity during aspirin/clopidogrel therapy or who have poor platelet inhibition by clopidogrel.
CONTRAST ADVERSE EFFECT STUDY OF ASPIRIN AND CLOPIDOGREL IN STROKE PATIENTS USING COMBINATION AND INDIVIDUAL MEDICATION  [PDF]
V.S. Giri Prasad,A.P. Ranjith kumar,Narender Karra,P.Prathyusha
International Research Journal of Pharmacy , 2012,
Abstract: Ischemia and hemorrhage are the conditions which may lead to stroke. As stroke is a medical emergency, treated with medications such as aspirin, clopidogrel and dipyridamole. In the present study the combination and individual adverse effects of aspirin and clopidogrel medication were studied. The study during was around nine months in one of the private hospital at Hyderabad, Andhra Pradesh, India. Adverse effects evaluation was based on WHO guide lines and Naranjo’s Algorithm. Total 69 stroke patients were taken in to studies. 46 (66.66%) were males and 23 (33.33%) were females. The number of ischemic stroke patients was 39(56.5%) and hemorrhage stroke was 30(43.4%). Among 41 patients, 19 patients was on Aspirin (46.34%), 10 patients was on clopidogral (24.34%) and 12 patients was on combinations medication (29.26%). Adverse effects reported among the antiplatelate users were 6 patients. Among these 6 patients 4 patients were observed with upper gastrointestinal bleeding (UGI) the overall percentage was 66.66% and 2 patients were observed with Vomiting, the overall percentage was 33.33%. In this study, the relative risk reduction for secondary stroke prevention was 37% with use of a combination of extended- release dipyridamole and aspirin. Importantly, the risk of major bleeding attributable to the combination therapy was no greater than that seen with aspirin alone. The benefit of clopidogrel over aspirin for the prevention of vascular events was a relative risk reduction of 8.7%.In addition, there was less major bleeding in the clopidogrel group, yielding a relative net benefit of about 10%. This study revels clopidogrel is the safe drug when compared with Aspirin and as well as combination therapy.
Comparative effect of clopidogrel plus aspirin and aspirin monotherapy on hematological parameters using propensity score matching
Hayasaka M, Takahashi Y, Nishida Y, Yoshida Y, Hidaka S, Asai S
Vascular Health and Risk Management , 2013, DOI: http://dx.doi.org/10.2147/VHRM.S39351
Abstract: mparative effect of clopidogrel plus aspirin and aspirin monotherapy on hematological parameters using propensity score matching Original Research (603) Total Article Views Authors: Hayasaka M, Takahashi Y, Nishida Y, Yoshida Y, Hidaka S, Asai S Published Date February 2013 Volume 2013:9 Pages 65 - 70 DOI: http://dx.doi.org/10.2147/VHRM.S39351 Received: 18 October 2012 Accepted: 10 December 2012 Published: 18 February 2013 Masatoshi Hayasaka,1 Yasuo Takahashi,2 Yayoi Nishida,2 Yoshikazu Yoshida,1 Shinji Hidaka,3 Satoshi Asai4 1Department of Pharmacy, Nihon University Itabashi Hospital, Tokyo, 2Division of Genomic Epidemiology and Clinical Trials, Clinical Trials Research Center, Nihon University School of Medicine, Tokyo, 3Laboratory of Pharmaceutical Regulatory Science, Department of Pharmacy, School of Pharmacy, Nihon University, Chiba, 4Division of Pharmacology, Department of Biomedical Sciences, Nihon University School of Medicine, Tokyo, Japan Background: Clopidogrel and aspirin are antiplatelet agents that are recommended to reduce the risk of recurrent stroke and other cardiovascular events. Dual antiplatelet therapy with clopidogrel and aspirin has been shown to increase the risk of hemorrhage, but the effects of the drugs on laboratory parameters have not been well studied in real-world clinical settings. Therefore, we evaluated and compared the effects of combination therapy with clopidogrel plus aspirin and aspirin monotherapy on laboratory parameters. Methods: We used data from the Nihon University School of Medicine Clinical Data Warehouse obtained between November 2004 and May 2011 to identify cohorts of new users (n = 130) of clopidogrel (75 mg/day) plus aspirin (100 mg/day) and a propensity score matched sample of new users (n = 130) of aspirin alone (100 mg/day). We used a multivariate regression model to compare serum levels of creatinine, aspartate aminotransferase, and alanine aminotransferase, as well as hematological parameters including hemoglobin level, hematocrit, and white blood cell, red blood cell, and platelet counts up to 2 months after the start of administration of the study drugs. Results: There were no significant differences for any characteristics and baseline laboratory parameters between users of clopidogrel plus aspirin and users of aspirin alone. Reductions in white blood cell and red blood cell counts, hemoglobin levels, and hematocrit in users of clopidogrel plus aspirin were significantly greater than those in users of aspirin alone. Conclusion: Our findings suggest that adverse hematological effects may be greater with combination clopidogrel plus aspirin therapy than with aspirin monotherapy.
Comparative effect of clopidogrel plus aspirin and aspirin monotherapy on hematological parameters using propensity score matching  [cached]
Hayasaka M,Takahashi Y,Nishida Y,Yoshida Y
Vascular Health and Risk Management , 2013,
Abstract: Masatoshi Hayasaka,1 Yasuo Takahashi,2 Yayoi Nishida,2 Yoshikazu Yoshida,1 Shinji Hidaka,3 Satoshi Asai41Department of Pharmacy, Nihon University Itabashi Hospital, Tokyo, 2Division of Genomic Epidemiology and Clinical Trials, Clinical Trials Research Center, Nihon University School of Medicine, Tokyo, 3Laboratory of Pharmaceutical Regulatory Science, Department of Pharmacy, School of Pharmacy, Nihon University, Chiba, 4Division of Pharmacology, Department of Biomedical Sciences, Nihon University School of Medicine, Tokyo, JapanBackground: Clopidogrel and aspirin are antiplatelet agents that are recommended to reduce the risk of recurrent stroke and other cardiovascular events. Dual antiplatelet therapy with clopidogrel and aspirin has been shown to increase the risk of hemorrhage, but the effects of the drugs on laboratory parameters have not been well studied in real-world clinical settings. Therefore, we evaluated and compared the effects of combination therapy with clopidogrel plus aspirin and aspirin monotherapy on laboratory parameters.Methods: We used data from the Nihon University School of Medicine Clinical Data Warehouse obtained between November 2004 and May 2011 to identify cohorts of new users (n = 130) of clopidogrel (75 mg/day) plus aspirin (100 mg/day) and a propensity score matched sample of new users (n = 130) of aspirin alone (100 mg/day). We used a multivariate regression model to compare serum levels of creatinine, aspartate aminotransferase, and alanine aminotransferase, as well as hematological parameters including hemoglobin level, hematocrit, and white blood cell, red blood cell, and platelet counts up to 2 months after the start of administration of the study drugs.Results: There were no significant differences for any characteristics and baseline laboratory parameters between users of clopidogrel plus aspirin and users of aspirin alone. Reductions in white blood cell and red blood cell counts, hemoglobin levels, and hematocrit in users of clopidogrel plus aspirin were significantly greater than those in users of aspirin alone.Conclusion: Our findings suggest that adverse hematological effects may be greater with combination clopidogrel plus aspirin therapy than with aspirin monotherapy.Keywords: clopidogrel, aspirin, laboratory parameter, antiplatelet therapy, propensity score matching
Is clopidogrel superior to aspirin in secondary prevention of vascular disease?
Ale Algra, Jan van Gijn
Trials , 2000, DOI: 10.1186/cvm-1-3-143
Abstract: A nice bottle of Graves arrived at our offices in early August 2000. The Dutch branch of Sanofi-Synthelabo sent this wine to collaborators of the Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE) trial [1] to celebrate the regulation of reimbursement for clopidogrel in the Netherlands on 26 July. The official indication for this novel antiplatelet drug reads: 'secondary prevention in patients with atherosclerotic disease and proven aspirin sensitivity'. Sanofi-Synthelabo appealed against the limitation to patients intolerant to aspirin, but lost the lawsuit [2].What is the background of this legal quarrel? The cornerstone is clinical evidence from the CAPRIE trial, a ran-domised, blinded, international study [1]. Clopidogrel (75 mg daily) and aspirin (325 mg daily) were compared in the prevention of the composite outcome event 'vascular death, nonfatal stroke or nonfatal myocardial infarction'. Clopidogrel reduced the annual risk of such a vascular event from 5.83 to 5.32% in comparison with aspirin, corresponding to a relative risk reduction (RRR) of 8.7%. The 95% confidence interval just kept clear of the neutral value and ranged from 0.3 to 16.5%. The design of the study was based on the paradigm prevalent in the early 1990s: all clinical presentations of atherosclerotic disease should be regarded as different manifestations of a single disorder of the arterial vascular tree. The data of the CAPRIE trial do not necessarily support this paradigm, because the RRR values of the three diagnostic strata (each with over 6000 patients) differed considerably: -3.7% for myocardial infarction, +7.3% for ischaemic stroke, and 23.8% for peripheral arterial disease (P = 0.042). A similar difference between different categories of atherosclerotic disease had been observed by the AntiPlatelet Trialists' Collaboration [3]. The RRR values achieved by aspirin (compared with placebo) ranged from 18% for cerebral ischaemia to 35% for unstable angina.Clopido
Ischaemic strokes : management in first six hours.  [cached]
Dalal P
Neurology India , 2001,
Abstract: Cerebrovascular disease (CVD) or stroke is one of the foremost causes of high morbidity and mortality for many nations of the world, posing a major socio-economic challenge in the occupational and neuro-rehabilitational programmes of the ′stroke-survivors′. For example, in USA alone it has been estimated that a sum of 3261 million dollars is spent as direct cost for treatment, in addition to 4104 million dollars as indirect costs, consequent on economic losses of ′stroke victims′. Thus, the new concept in stroke pathophysiology and strategies for stroke prevention have assumed global importance. Among all risk factors for strokes, hypertension is one of the most important and treatable factor. Community screening surveys, by well defined WHO protocol, have shown that nearly 15% of urban population is hypertensive (160/95 mm Hg or more). Though high blood pressure has the highest attributable risk for stroke, there are many other reasons such as patient′s compliance in taking medicine and poor followup in clinical practice that may lead to failure in reducing stroke mortality. In subjects, who have transient ischaemic attacks (TIAs), regular use of antiplatelet agents like aspirin is well established in prevention of stroke. It is also mandatory to prohibit tobacco use and adjust dietary habits to control body weight. Associated conditions like diabetes mellitus etc. should also be treated. It is advisable to initiate community screening surveys on well defined populations for early detection of hypertension and TIAs. Primary health care centres should be the base stations for these surveys, because data gathered from urban hospitals will not truly reflect the crude prevalence rates for the community to design practical prevention programmes.
Aspirin plus Pseudoephedrine (Aspirin Complex) for the Treatment of Symptoms of Upper Respiratory Tract Infection  [PDF]
Michael Voelker, Ronald Eccles, Uwe Gessner
Open Journal of Respiratory Diseases (OJRD) , 2017, DOI: 10.4236/ojrd.2017.71004
Abstract: Upper respiratory tract infections or common colds are a multi-symptom disease which is usually symptomatically treated with fixed dose multi-active ingredient medicinal products which are commonly used as non-prescription and over the counter. However, the active ingredients combined require a particular and clinically sound justification. Analgesics and decongestant can be combined to treat simultaneously the prominent symptoms cold-related pain (e.g. headache, muscle aches and pains), fever, inflammationand nasal/sinus congestion. This overview provides a summary of the evidence supporting the combination of acetylsalicylic acid (aspirin) and pseudoephedrine available in the common cold product Aspirin? Complex.
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