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Brief Summary

GUIDELINE TITLE

Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome. London (UK): National Institute for Clinical Excellence (NICE); 2004 Jul. 24 p. (Technology appraisal; no. 80).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s)/intervention(s) for which important revised regulatory and/or warning information has been released.

  • June 8, 2007, Troponin-I Immunoassay: Class I Recall of all lots of the Architect Stat Troponin-I Immunoassay. The assay may report falsely elevated or falsely decreased results at and near a low level, which may impact patient treatment.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Clopidogrel, in combination with low-dose aspirin, is recommended for use in the management of non-ST segment-elevation acute coronary syndrome (ACS) in people who are at moderate to high risk of myocardial infarction (MI) or death.
  • For the purposes of this guidance, moderate to high risk of MI or death in people presenting with non-ST-segment elevation ACS can be determined by clinical signs and symptoms, accompanied by one or both of the following:
    • the results of clinical investigations, such as new electrocardiogram (ECG) changes (other than persistent ST-segment-elevation), indicating ongoing myocardial ischaemia, particularly dynamic or unstable patterns
    • the presence of raised blood levels of markers of cardiac cell damage such as troponin.
  • It is recommended that treatment with clopidogrel in combination with low-dose aspirin should be continued for up to 12 months after the most recent acute episode of non-ST-segment-elevation ACS (as defined above). Thereafter, standard care, including treatment with low-dose aspirin alone, is recommended.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

For the assessment of the clinical effectiveness of clopidogrel alone or in combination with aspirin one randomised controlled trial (RCT) was identified (the Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators [CURE]). The study was a randomised, double-blind, placebo controlled trial of high quality. A further five systematic reviews of varying quality examined the adverse events associated with long-term aspirin use.

Of the cost-effectiveness evidence reviewed, only the manufacturer's submission was considered relevant from the perspective of the National Health Service (NHS). The review of this evidence highlighted potential limitations within the submission in its use of data and in the model structure used. These limitations led to the development of a new model with the aim of providing a more reliable estimate of the cost-effectiveness from the perspective of the UK NHS.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome. London (UK): National Institute for Clinical Excellence (NICE); 2004 Jul. 24 p. (Technology appraisal; no. 80).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Jul

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Dr Jane Adam, Radiologist, St George's Hospital, London; Dr Sunil Angris, General Practitioner, Waterhouses Medical Practice, Staffordshire; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Professor Stirling Bryan, Professor of Health Economics, Health Economics Facility, Health Services Management Centre, University of Birmingham; Professor John Cairns, Professor of Health Economics, Health Economics Research Unit, University of Aberdeen; Professor David Chadwick, Professor of Neurology, Department of Neurological Science, Walton Centre for Neurology & Neurosurgery, Liverpool; Dr Lorna Duggan, Consultant Forensic Psychiatrist in Developmental Disabilities, St Andrew's Hospital, Northampton; Mrs Fiona Duncan, Clinical Nurse Specialist, Anaesthetic Department, Blackpool Victoria Hospital, Blackpool; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Dr Trevor Gibbs Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, Greenford; Mr Sanjay Gupta, Stroke Services Manager, Basildon & Thurrock University Hospitals NHS Trust; Professor Philip Home (Vice-Chair) Professor of Diabetes Medicine, Department of Medicine, University of Newcastle upon Tyne; Dr Peter Jackson, Clinical Pharmacologist, Molecular & Clinical Pharmacology, University of Sheffield; Dr Terry John, General Practitioner, The Firs, London; Dr Mike Laker, Medical Director, Newcastle Hospitals NHS Trust, Royal Victoria Infirmary, Newcastle- Upon-Tyne; Dr George Levvy, Chief Executive, Motor Neurone Disease Association, Northampton; Professor Richard Lilford, Professor of Clinical Epidemiology, Department of Public Health & Epidemiology, University of Birmingham; Professor John Lumley, Honorary Consultant, The Ernest Cooke Clinic Microvascular Unit, Great Ormond Street, Bart's and the Royal London NHS Trust, Barbican, London; Dr Simon Mitchell, Consultant Neonatal Paediatrician, St Mary's Hospital, Manchester; Dr Virginia Pearson, Chief Executive, South Petherton Hospital, South Somerset PCT; Dr Christa Roberts, UK Manager, Vascular Intervention, Guidant Ltd; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Dr Lindsay Smith, General Practitioner, Westlake Surgery, Somerset; Mr Mike Spencer, General Manager, Clinical Support Services, Cardiff and Vale NHS Trust; Dr Rod Taylor, Senior Lecturer, Department of Public Health & Epidemiology, University of Birmingham; Professor Mary Watkins, Professor of Nursing, University of Plymouth; Dr Norman Waugh, Department of Public Health, University of Aberdeen; Mrs Miranda Wheatley-Price, Director of Service Development, Colon Cancer Concern, London

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N0613. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

  • Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome. Understanding NICE guidance - information for people with non-ST-segment-elevation acute coronary syndrome, their families and carers, and the public. London (UK): National Institute for Health and Clinical Excellence (NICE); 2004 Jul. 10 p. (Technology appraisal 80).

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the Department of Health Publications Order Line 0870 1555 455. ref: N0614. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

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