Welcome to NGC. Skip directly to: Search Box, Navigation, Content.


Brief Summary

GUIDELINE TITLE

Anticoagulants and antiplatelet agents in acute ischemic stroke: report of the Joint Stroke Guideline Development Committee of the American Academy of Neurology and the American Stroke Association (a division of the American Heart Association).

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

According to the guideline developer, this guideline has been reviewed and is still considered to be current as of October 2005. This review involved new literature searches of electronic databases followed by expert committee review of new evidence that has emerged since the original publication date.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

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

  • December 3, 2008, Innohep (tinzaparin): The U.S. Food and Drug Administration (FDA) has requested that the labeling for Innohep be revised to better describe overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both.
  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.

BRIEF SUMMARY CONTENT

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

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions of the levels of evidence (Class I-IV) and grades of recommendation (Grade A-C) are provided at the end of the Major Recommendations field.

  1. Patients with acute ischemic stroke presenting within 48 hours of symptom onset should be given aspirin (160 to 325 mg/day) to reduce stroke mortality and decrease morbidity, provided contraindications such as allergy and gastrointestinal bleeding are absent, and the patient has not been or will not be treated with recombinant tissue type plasminogen activator (Grade A). The data are insufficient at this time to recommend the use of any other platelet antiaggregant in the setting of acute ischemic stroke.
  2. Subcutaneous unfractionated heparin, low molecular weight (LMW) heparins, and heparinoids may be considered for deep vein thrombosis (DVT) prophylaxis in at-risk patients with acute ischemic stroke, recognizing that nonpharmacologic treatments for DVT prevention also exist (Grade A). A benefit in reducing the incidence of pulmonary embolism (PE) has not been demonstrated. The relative benefits of these agents must be weighed against the risk of systemic and intracerebral hemorrhage.
  3. Although there is some evidence that fixed-dose, subcutaneous, unfractionated heparin reduces early recurrent ischemic stroke, this benefit is negated by a concomitant increase in the occurrence of hemorrhage. Therefore, use of subcutaneous unfractionated heparin is not recommended for decreasing the risk of death or stroke-related morbidity or for preventing early stroke recurrence (Grade A).
  4. A. Dose-adjusted, unfractionated heparin is not recommended for reducing morbidity, mortality, or early recurrent stroke in patients with acute stroke (i.e., in the first 48 hours) because the evidence indicates it is not efficacious and may be associated with increased bleeding complications (Grade B).
  1. B. High-dose LMW heparin/heparinoids have not been associated with either benefit or harm in reducing morbidity, mortality, or early recurrent stroke in patients with acute stroke and are, therefore, not recommended for these goals (Grade A).
  2. Intravenous (IV), unfractionated heparin or high dose LMW heparin/heparinoids are not recommended for any specific subgroup of patients with acute ischemic stroke that is based on any presumed stroke mechanism or location (e.g., cardioembolic, large vessel atherosclerotic, vertebrobasilar, or "progressing" stroke) because data are insufficient (Grade U). Although the LMW heparin dalteparin at high doses may be efficacious in patients with atrial fibrillation, it is not more efficacious than aspirin in this setting. Because aspirin is easier to administer, it, rather than dalteparin, is recommended for the various stroke subgroups (Grade A).

Definitions:

Levels of Evidence

Class I: Evidence provided by a prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. The following are required:

  • Primary outcome(s) is/are clearly defined.
  • Exclusion/inclusion criteria are clearly defined.
  • Adequate accounting for drop outs and crossovers with numbers sufficiently low to have minimal potential for bias.
  • Relevant baseline characteristics are presented and substantially equivalent among treatment groups, or there is appropriate statistical adjustment for differences.

Class II: Evidence provided by a prospective, matched cohort study in a representative population with masked outcome assessment that meets all of the above OR a randomized controlled trial in a representative population that lacks one of the above criteria.

Class III: Evidence provided by all other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, in which outcome assessment is independent of patient treatment.

Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion.

Grade of Recommendation

Grade A. At least one convincing Class I study or at least two consistent, convincing Class II studies.

Grade B. At least one convincing Class II study or at least three convincing Class III studies.

Grade C. At least two convincing and consistent Class III studies.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2002 Jul (reviewed 2005 Oct)

GUIDELINE DEVELOPER(S)

American Academy of Neurology - Medical Specialty Society
American Stroke Association - Disease Specific Society

SOURCE(S) OF FUNDING

American Academy of Neurology (AAN)

GUIDELINE COMMITTEE

Joint Stroke Guideline Development Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Joint Stroke Guideline Development Committee: Milton Alter, MD, PhD (Co-Chair, American Academy of Neurology); George J. Hademenos, PhD (Co-Chair, American Heart Association); Larry B. Goldstein, MD; Philip B. Gorelick, MD, MPH; Chung Y. Hsu, MD, PhD; Jose Biller, MD; and Wendy Edlund

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

According to the guideline developer, this guideline has been reviewed and is still considered to be current as of October 2005. This review involved new literature searches of electronic databases followed by expert committee review of new evidence that has emerged since the original publication date.

GUIDELINE AVAILABILITY

Electronic copies: A list of American Academy of Neurology (AAN) guidelines, along with a link to a Portable Document Format (PDF) file for this guideline, is available at the AAN Web site.

Print copies: Available from the AAN Member Services Center, (800) 879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

Get With the Guidelines (GWTG) provides disease-specific process documents and tools for in-house quality improvement. See the American Heart Association Web site for more information. See the related QualityTool summary on the Health Care Innovations Exchange Web site for this related tool set.

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on February 6, 2004. This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on March 13, 2008 following the updated FDA advisory on heparin sodium injection. This summary was updated by ECRI Institute on December 26, 2008 following the FDA advisory on Innohep (tinzaparin).

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
DHHS Logo