Latest & greatest articles for clopidogrel

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Top results for clopidogrel

41. Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland (PubMed)

Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland To assess safety up to 1 year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes (ACS).Between 2009 and 2012, 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort, among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines. Patients (...) with ST-elevation myocardial infarction (STEMI) preferentially received prasugrel, while those with non-STEMI, a history of stroke or transient ischaemic attack, age ≥75 years, or weight <60 kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label.After adjustment using propensity scores, the primary end point of clinically relevant bleeding events (defined as the composite of Bleeding Academic Research Consortium, BARC, type 3, 4 or 5 bleeding) at 1 year, occurred

2015 EvidenceUpdates

42. Long term use of clopidogrel for patients with stents or acute coronary syndrome: a review of clinical and cost-effectiveness and guidelines

Long term use of clopidogrel for patients with stents or acute coronary syndrome: a review of clinical and cost-effectiveness and guidelines Long term use of clopidogrel for patients with stents or acute coronary syndrome: a review of clinical and cost-effectiveness and guidelines Long term use of clopidogrel for patients with stents or acute coronary syndrome: a review of clinical and cost-effectiveness and guidelines CADTH Record Status This is a bibliographic record of a published health (...) technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Long term use of clopidogrel for patients with stents or acute coronary syndrome: a review of clinical and cost-effectiveness and guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response - Summary with Critical Appraisal. 2013 Authors' conclusions There appears to be uncertainty regarding the effectiveness of use

2014 Health Technology Assessment (HTA) Database.

43. Clopidogrel/Acetylsalicylic acid Teva

Clopidogrel/Acetylsalicylic acid Teva 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 26 June 2014 EMA/CHMP/333195/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Clopidogrel / Acetylsalicylic acid (...) Teva International non-proprietary name: clopidogrel / acetylsalicylic acid Procedure No. EMEA/H/C/002272/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised Assessment report EMA/502333/2014 Page 2/43 Table of contents 1. Background information on the procedure 6 2. Scientific discussion 8 2.1. Quality aspects 8 2.2. Non-clinical aspects 13 2.3. Clinical aspects 19 2.4. Clinical efficacy 28

2014 European Medicines Agency - EPARs

44. Clopidogrel Qualimed

Clopidogrel Qualimed European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged. Doc. Ref.:EMEA/506895/2009 CHMP ASSESSMENT REPORT FOR Clopidogrel Qualimed International Nonproprietary Name: clopidogrel Procedure No. EMEA/H/C/001135 Assessment Report as adopted by the CHMP (...) no longer authorised 1. BACKGROUND INFORMATION ON THE PROCEDURE 1.1 Submission of the dossier Qualimed submitted on 20 February 2009 an application for Marketing Authorisation to the European Medicines Agency (EMEA) for Clopidogrel Qualimed , in accordance with the centralised procedure falling within the scope of the Annex to Regulation (EC) 726/2004 under Article 3 (3) – ‘Generic of a Centrally authorised product’. The legal basis for this application refers to Article 10(1) of Directive 2001/83/EC

2014 European Medicines Agency - EPARs

45. Clopidogrel in infants with systemic-to-pulmonary-artery shunts

Clopidogrel in infants with systemic-to-pulmonary-artery shunts PEDSCCM.org Criteria abstracted from series in Review Posted: founded 1995 Questions or comments?

2013 PedsCCM Evidence-Based Journal Club

46. Endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy: to do or not to do?

Endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy: to do or not to do? Endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy: to do or not to do? Endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy: to do or not to do? Samie AA, Theilmann L CRD summary This review concluded that data on bleeding risk of endoscopic procedures in patients under clopidogrel/antiplatelet therapy were scarce and poor quality (...) , but that there was no evidence to support the recommendations to stop clopidogrel prior to high-risk endoscopic procedures. The potential for missed studies, lack of quality assessment and inappropriate synthesis mean these conclusions may not be reliable. Authors' objectives To determine the bleeding risk with gastrointestinal endoscopic procedures performed in patients under clopidogrel/dual antiplatelet therapy. Searching MEDLINE, EMBASE and The Cochrane Library were searched for English language studies up to October

2013 DARE.

47. Long term Use of Clopidogrel for Patients with Stents or Acute Coronary Syndrome

Long term Use of Clopidogrel for Patients with Stents or Acute Coronary Syndrome TITLE: Long term Use of Clopidogrel for Patients with Stents or Acute Coronary Syndrome: A Review of Clinical and Cost-effectiveness and Guidelines DATE: 15 August 2013 CONTEXT AND POLICY ISSUES Ischemic heart disease refers to a wide range of conditions resulting from reduced blood flow to the heart and is one of the leading causes of death and disability. 1,2 It includes conditions such as acute coronary syndrome (...) that antiplatelet therapy prevents the occurrence of ischemic events by inhibition of platelet thrombus formation and protects distal tissues by maintaining the flow of blood. 3 Clopidogrel is an antiplatelet agent and is frequently used in antiplatelet therapy. Clopidogrel is a thioenopyridine that binds to P2Y 12 receptor and subsequently inhibits platelet aggregation. It is a prodrug that is converted to an active metabolite for biological activity. 4 There is uncertainty surrounding optimal duration

2013 Canadian Agency for Drugs and Technologies in Health - Rapid Review

48. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. (PubMed)

Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed (...) outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen.TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management without [corrected] revascularisation were randomly assigned to clopidogrel or prasugrel.The primary endpoint was cardiovascular death, myocardial infarction, or stroke

2013 Lancet

49. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. (PubMed)

Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. Stroke is common during the first few weeks after a transient ischemic attack (TIA) or minor ischemic stroke. Combination therapy with clopidogrel and aspirin may provide greater protection against subsequent stroke than aspirin alone.In a randomized, double-blind, placebo-controlled trial conducted at 114 centers in China, we randomly assigned 5170 patients within 24 hours after the onset of minor ischemic stroke (...) or high-risk TIA to combination therapy with clopidogrel and aspirin (clopidogrel at an initial dose of 300 mg, followed by 75 mg per day for 90 days, plus aspirin at a dose of 75 mg per day for the first 21 days) or to placebo plus aspirin (75 mg per day for 90 days). All participants received open-label aspirin at a clinician-determined dose of 75 to 300 mg on day 1. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. Treatment

2013 NEJM

50. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. (PubMed)

Clopidogrel in infants with systemic-to-pulmonary-artery shunts. Infants with cyanotic congenital heart disease palliated with placement of a systemic-to-pulmonary-artery shunt are at risk for shunt thrombosis and death. We investigated whether the addition of clopidogrel to conventional therapy reduces mortality from any cause and morbidity related to the shunt.In a multicenter, double-blind, event-driven trial, we randomly assigned infants 92 days of age or younger with cyanotic congenital (...) heart disease and a systemic-to-pulmonary-artery shunt to receive clopidogrel at a dose of 0.2 mg per kilogram of body weight per day (467 infants) or placebo (439 infants), in addition to conventional therapy (including aspirin in 87.9% of infants). The primary efficacy end point was a composite of death or heart transplantation, shunt thrombosis, or performance of a cardiac procedure due to an event considered to be thrombotic in nature before 120 days of age.The rate of the composite primary end

2013 NEJM

51. Efficacy of Clopidogrel Reloading in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention During Chronic Clopidogrel Therapy (from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty [ARMYDA-8 RELO (PubMed)

Efficacy of Clopidogrel Reloading in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention During Chronic Clopidogrel Therapy (from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty [ARMYDA-8 RELO Whether an additional clopidogrel load in patients receiving chronic clopidogrel therapy and undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is associated with clinical benefit has not been well (...) characterized. The aim of the present study was to evaluate, in a randomized protocol, the safety and effectiveness of clopidogrel reload for patients with ACS undergoing PCI in the background of chronic clopidogrel therapy. A total of 242 patients with non-ST-segment elevation ACS with >10 days of clopidogrel therapy randomly received a 600-mg loading dose of clopidogrel 4 to 8 hours before PCI (n = 122) or placebo (n = 120). The primary end point was the 30-day incidence of major adverse cardiac events

2013 EvidenceUpdates

52. Impact of clopidogrel and potent P2Y12-inhibitors on mortality and stroke in patients with acute coronary syndrome or undergoing percutaneous coronary intervention: a systematic review and meta-analysis

Impact of clopidogrel and potent P2Y12-inhibitors on mortality and stroke in patients with acute coronary syndrome or undergoing percutaneous coronary intervention: a systematic review and meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2013 DARE.

53. Protective Effects of Tranexamic Acid on Clopidogrel Before Coronary Artery Bypass Grafting: A Multicenter Randomized Trial (PubMed)

Protective Effects of Tranexamic Acid on Clopidogrel Before Coronary Artery Bypass Grafting: A Multicenter Randomized Trial Excessive bleeding and transfusion increase morbidity and mortality in patients receiving coronary artery bypass grafting (CABG), especially in those exposed to antiplatelet agents.To evaluate the influence and interaction of clopidogrel bisulfate and tranexamic acid on bleeding and transfusion outcomes.A multicenter randomized and blinded trial.Seven medical centers (...) across China.Patients eligible for randomization were 1173 men and women aged 18 to 85 years undergoing primary and isolated on-pump CABG; 570 adults were randomized and 552 were analyzed. Patients were recruited and stratified into 3 levels according to preoperative clopidogrel exposure (clopidogrel ingestion ≤7 days, clopidogrel discontinuation >7 days, and nonexposure).Patients were randomized to receive tranexamic acid (10-mg/kg-1 bolus and 10-mg/kg-1/h-1 maintenance dose) or placebo.The primary

Full Text available with Trip Pro

2013 EvidenceUpdates

54. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. (PubMed)

Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. If percutaneous coronary intervention (PCI) is required in patients taking oral anticoagulants, antiplatelet therapy with aspirin and clopidogrel is indicated, but such triple therapy increases the risk of serious bleeding. We investigated the safety and efficacy of clopidogrel alone compared with clopidogrel (...) plus aspirin.We did an open-label, multicentre, randomised, controlled trial in 15 centres in Belgium and the Netherlands. From November, 2008, to November, 2011, adults receiving oral anticoagulants and undergoing PCI were assigned clopidogrel alone (double therapy) or clopidogrel plus aspirin (triple therapy). The primary outcome was any bleeding episode within 1 year of PCI, assessed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769938.573 patients were

2013 Lancet

55. Reduction in First and Recurrent Cardiovascular Events With Ticagrelor Compared With Clopidogrel in the PLATO Study (PubMed)

Reduction in First and Recurrent Cardiovascular Events With Ticagrelor Compared With Clopidogrel in the PLATO Study We sought to evaluate the effect of potent platelet inhibition after acute coronary syndrome on total (ie, first and recurrent) occurrences of any of the primary outcome events (e.g., cardiovascular death, myocardial infarction, and stroke) as well as on other ischemic events, such as urgent revascularization, (severe) recurrent ischemia, transient ischemic attacks, and arterial (...) thrombotic events.In the PLATelet inhibition and patient Outcomes (PLATO) study, 18 624 patients presenting with acute coronary syndromes randomly received ticagrelor (n=9333) or clopidogrel (n=9291). Cox proportional hazard models were used to calculate time to first event and hazard ratios. Total events were compared using a Poisson regression model, and time to second event or death was calculated with the Wei Lin Weissfeld method. Patients randomized to ticagrelor had 1057 total primary end point

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2013 EvidenceUpdates

56. Adverse cardiovascular effects of concomitant use of proton pump inhibitors and clopidogrel in patients with coronary artery disease: a systematic review and meta-analysis

Adverse cardiovascular effects of concomitant use of proton pump inhibitors and clopidogrel in patients with coronary artery disease: a systematic review and meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2013 DARE.

57. Cost-effectiveness of clopidogrel plus aspirin for stroke prevention in patients with atrial fibrillation in whom warfarin is unsuitable

Cost-effectiveness of clopidogrel plus aspirin for stroke prevention in patients with atrial fibrillation in whom warfarin is unsuitable Cost-effectiveness of clopidogrel plus aspirin for stroke prevention in patients with atrial fibrillation in whom warfarin is unsuitable Cost-effectiveness of clopidogrel plus aspirin for stroke prevention in patients with atrial fibrillation in whom warfarin is unsuitable Coleman CI, Straznitskas AD, Sobieraj DM, Kluger J, Anglade MW Record Status (...) This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study assessed the cost-effectiveness of clopidogrel plus aspirin, compared with aspirin alone, for the prevention of stroke in patients with uncomplicated atrial fibrillation. The authors concluded

2013 NHS Economic Evaluation Database.

58. Transient ischaemic attack: clopidogrel

Transient ischaemic attack: clopidogrel T T r ransient ischaemic attack: clopidogrel ansient ischaemic attack: clopidogrel Evidence summary Published: 13 December 2013 nice.org.uk/guidance/esuom23 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in December 2013. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Summary No relevant (...) randomised controlled trials (RCTs) were identified that assessed clopidogrel monotherapy in people who have had a transient ischaemic attack (TIA). In addition, no high quality observational data were identified on the efficacy of clopidogrel monotherapy in people with TIA. Limited RCT evidence was identified for the use of clopidogrel in combination with aspirin for TIA. Regulatory status: Regulatory status: off-label This topic of transient ischaemic attack: clopidogrel was chosen for an evidence

2013 National Institute for Health and Clinical Excellence - Advice

59. Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C19 Genotype and Clopidogrel Therapy

Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C19 Genotype and Clopidogrel Therapy CPIC UPdate nature publishing group Cytochrome P450 (CYP)2C19 catalyzes the bioactivation of the antiplatelet prodrug clopidogrel, and CYP2C19 loss- of-function alleles impair formation of active metabolites, resulting in reduced platelet inhibition. In addition, CYP2C19 loss-of-function alleles confer increased risks for serious adverse cardiovascular (CV) events among clopidogrel (...) , diabetes mellitus, obesity, smoking, and concomitant use of other drugs that may influence clopidogrel efficacy and clinical decision making. The CPIC of the National Institutes of Health’s Pharmacogenomics Research Network and PharmGKB develops peer-reviewed gene/drug guidelines that are published and updated on www.pharmgkb. org every 2 years or as needed based on significant developments in the field. 2 FOCUSED LITERATURE REVIEW A systematic literature review was conducted on CYP2C19 geno- type

2013 Clinical Pharmacogenetics Implementation Consortium

60. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial.

Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed (...) outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen.TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management without [corrected] revascularisation were randomly assigned to clopidogrel or prasugrel.The primary endpoint was cardiovascular death, myocardial infarction, or stroke

2013 Lancet