This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (72)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Neurology  • Cerebrovascular Disease  • Stroke  • Randomized Controlled Trial  • Alert me on articles by topic

A Randomized Trial

Philip B. Gorelick, MD, MPH; DeJuran Richardson, PhD; Michael Kelly, MD; Sean Ruland, DO; Elena Hung, MS; Yvonne Harris, MPA, CCRA; Steven Kittner, MD, MPH; Sue Leurgans, PhD; for the African American Antiplatelet Stroke Prevention Study (AAASPS) Investigators

JAMA. 2003;289:2947-2957.

Context  Blacks are disproportionately affected by stroke, and they are about 2 times more likely than most other individuals in the United States to die of or experience stroke.

Objective  To determine the efficacy and safety of aspirin and ticlopidine to prevent recurrent stroke in black patients.

Design, Setting, and Patients  Randomized, double-blind, investigator-initiated, multicenter trial of 1809 black men and women who recently had a noncardioembolic ischemic stroke and who were recruited between December 1992 and October 2001 from 62 academic and community hospitals in the United States and followed up for up to 2 years.

Intervention  A total of 902 patients received 500 mg/d of ticlopidine and 907 received 650 mg/d of aspirin.

Main Outcome Measures  Recurrent stroke, myocardial infarction, or vascular death was the composite primary end point (according to intention-to-treat analysis). The secondary outcome was fatal or nonfatal stroke.

Results  The blinded phase of the study was halted after about 6.5 years when futility analyses revealed a less than 1% probability of ticlopidine being shown superior to aspirin in the prevention of the primary outcome end point. The primary outcome of recurrent stroke, myocardial infarction, or vascular death was reached by 133 (14.7%) of 902 patients assigned to ticlopidine and 112 (12.3%) of 907 patients assigned to aspirin (hazard ratio, 1.22; 95% confidence interval, 0.94-1.57). Kaplan-Meier curves for time to event for the primary outcome did not differ significantly (P = .12 by log-rank test). Kaplan-Meier curves for time to the secondary outcome of fatal or nonfatal stroke approached a statistically significant reduction favoring aspirin over ticlopidine (P = .08 by log-rank test). The frequency of laboratory-determined serious neutropenia was 3.4% for patients receiving ticlopdine vs 2.2% for patients receiving aspirin (P = .12) and 0.3% vs 0.2% for thrombocytopenia, respectively (P = .69). One ticlopidine-treated patient developed thrombocytopenia, which was thought to be a case of possible thrombotic thrombocytopenia purpura, and recovered after therapy with plasmapheresis.

Conclusions  During a 2-year follow-up, we found no statistically significant difference between ticlopidine and aspirin in the prevention of recurrent stroke, myocardial infarction, or vascular death. However, there was a nonsignificant trend for reduction of fatal or nonfatal stroke among those in the aspirin group. Based on these data and the risk of serious adverse events with ticlopidine, we regard aspirin as a better treatment for aspirin-tolerant black patients with noncardioembolic ischemic stroke.

Author Affiliations: Departments of Neurologic Sciences (Drs Gorelick, Ruland, and Leurgans, and Ms Harris) and Preventive Medicine (Dr Richardson and Ms Hung), Rush Medical College, Chicago, Ill; Department of Mathematics and Computer Science, Lake Forest College, Lake Forest, Ill (Dr Richardson); Department of Medicine, Division of Neurology, Cook County Hospital, Chicago, Ill (Dr Kelly); and the Department of Neurology, University of Maryland, Baltimore (Dr Kittner).

RELATED ARTICLE

Preventing Stroke Among Blacks: The Challenges Continue
Ralph L. Sacco
JAMA. 2003;289(22):3005-3007.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Review: Recurrent stroke: where do we stand with the secondary prevention of noncardioembolic ischaemic strokes?
Talelli and Greenwood
Therapeutic Advances in Cardiovascular Disease 2008;2:387-405.
ABSTRACT  

Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke
Sacco et al.
NEJM 2008;359:1238-1251.
ABSTRACT | FULL TEXT  

Large Artery Intracranial Occlusive Disease: A Large Worldwide Burden but a Relatively Neglected Frontier
Gorelick et al.
Stroke 2008;39:2396-2399.
ABSTRACT | FULL TEXT  

Antithrombotic and Thrombolytic Therapy for Ischemic Stroke: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Albers et al.
Chest 2008;133:630S-669S.
ABSTRACT | FULL TEXT  

Network meta-analysis of antiplatelet treatments for secondary stroke prevention
Baumgartner
Eur Heart J 2008;29:1082-1083.
FULL TEXT  

Network meta-analysis: simultaneous meta-analysis of common antiplatelet regimens after transient ischaemic attack or stroke
Thijs et al.
Eur Heart J 2008;29:1086-1092.
ABSTRACT | FULL TEXT  

Antiplatelet Therapy for Secondary Prevention of Noncardioembolic Ischemic Stroke: A Critical Review
O'Donnell et al.
Stroke 2008;39:1638-1646.
ABSTRACT | FULL TEXT  

NINDS Clinical Trials in Stroke: Lessons Learned and Future Directions
Marler
Stroke 2007;38:3302-3307.
ABSTRACT | FULL TEXT  

Risk factor status and vascular events in patients with symptomatic intracranial stenosis
Chaturvedi et al.
Neurology 2007;69:2063-2068.
ABSTRACT | FULL TEXT  

Risk of Myocardial Infarction or Vascular Death After First Ischemic Stroke: The Northern Manhattan Study
Dhamoon et al.
Stroke 2007;38:1752-1758.
ABSTRACT | FULL TEXT  

Combining Aspirin With Oral Anticoagulant Therapy: Is This a Safe and Effective Practice in Patients With Atrial Fibrillation?
Gorelick
Stroke 2007;38:1652-1654.
FULL TEXT  

Secondary Prevention of Stroke and Transient Ischemic Attack: Is More Platelet Inhibition the Answer?
Liao
Circulation 2007;115:1615-1621.
ABSTRACT | FULL TEXT  

Uncertainty of Management of Blood Pressure and Lipids in the Elderly: Time for a Primary Prevention Trial
Gorelick
Stroke 2007;38:212-213.
FULL TEXT  

Advancing the Study of Stroke in Women: Summary and Recommendations for Future Research From an NINDS-Sponsored Multidisciplinary Working Group
Bushnell et al.
Stroke 2006;37:2387-2399.
ABSTRACT | FULL TEXT  

August 22 Highlight and Commentary: Predictors of recurrent stroke in African Americans
Neurology 2006;67:553-553.
FULL TEXT  

Predictors of recurrent stroke in African Americans.
Ruland et al.
Neurology 2006;67:567-571.
ABSTRACT | FULL TEXT  

Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline.
Sacco et al.
Circulation 2006;113:e409-e449.
ABSTRACT | FULL TEXT  

Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline.
Sacco et al.
Stroke 2006;37:577-617.
ABSTRACT | FULL TEXT  

Secondary Stroke Prevention With Antiplatelet Therapy With Emphasis on the Cardiac Patient: A Neurologist's View
Gebel
J Am Coll Cardiol 2005;46:752-755.
ABSTRACT | FULL TEXT  

Review of Antiplatelet Therapy in Secondary Prevention of Cerebrovascular Events: A Need for Direct Comparisons Between Antiplatelet Agents
Jamieson et al.
J CARDIOVASC PHARMACOL THER 2005;10:153-161.
ABSTRACT  

Avoiding Central Nervous System Bleeding During Antithrombotic Therapy: Recent Data and Ideas
Hart et al.
Stroke 2005;36:1588-1593.
ABSTRACT | FULL TEXT  

Adding aspirin to clopidogrel after TIA and ischemic stroke: Benefits do not match risks
Hankey and Eikelboom
Neurology 2005;64:1117-1121.
ABSTRACT | FULL TEXT  

Emerging Therapies: Clopidogrel and Aspirin
Moussouttas
Stroke 2005;36:707-707.
FULL TEXT  

Comparison of Warfarin and Aspirin for Symptomatic Intracranial Arterial Stenosis
Chimowitz et al.
NEJM 2005;352:1305-1316.
ABSTRACT | FULL TEXT  

Impact of Obesity and the Metabolic Syndrome on Risk Factors in African American Stroke Survivors: A Report From the AAASPS
Ruland et al.
Arch Neurol 2005;62:386-390.
ABSTRACT | FULL TEXT  

Clinically Translated Ischemic Stroke Genomics
Meschia
Stroke 2004;35:2735-2739.
ABSTRACT | FULL TEXT  

"Lacunarization" of Stroke Prevention Studies
Chaturvedi
Stroke 2004;35:2238-2239.
FULL TEXT  

Antithrombotic and Thrombolytic Therapy for Ischemic Stroke: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy
Albers et al.
Chest 2004;126:483S-512S.
ABSTRACT | FULL TEXT  

Pharmacological Characterization of N-tert-Butyl-N'-[2-(4'-methylphenylamino)-5-nitrobenzenesulfonyl]urea (BM-573), a Novel Thromboxane A2 Receptor Antagonist and Thromboxane Synthase Inhibitor in a Rat Model of Arterial Thrombosis and Its Effects on Bleeding Time
Dogne et al.
J. Pharmacol. Exp. Ther. 2004;309:498-505.
ABSTRACT | FULL TEXT  

Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice
Deyo
J Am Board Fam Med 2004;17:142-149.
ABSTRACT | FULL TEXT  

Serial Urinary 11-Dehydrothromboxane B2, Aspirin Dose, and Vascular Events in Blacks After Recent Cerebral Infarction
Bruno et al.
Stroke 2004;35:727-730.
ABSTRACT | FULL TEXT  

Prevention and Health Services Delivery
Goldstein and Amarenco
Stroke 2004;35:401-403.
FULL TEXT  

ADDITIONAL ARTICLES ABSTRACTED IN ACP JOURNAL CLUB
Evid. Based Med. 2004;9:3-3.
FULL TEXT  

Race, ethnic group, and clinical research
Rathore and Krumholz
BMJ 2003;327:763-764.
FULL TEXT  

Potential Value of Triple Antiplatelet Therapy for Secondary Stroke Prevention
Jonas and Grieco
Stroke 2003;34 :e182-e183.
FULL TEXT  

Aspirin or Ticlopidine for Preventing Recurrent Stroke in Black Patients?
JWatch General 2003;2003:3-3.
FULL TEXT  

Cardiovascular News
SoRelle
Circulation 2003;107 :e9050-e9051.
FULL TEXT  

Preventing Stroke Among Blacks: The Challenges Continue
Sacco
JAMA 2003;289:3005-3007.
FULL TEXT