SKYAID
 New 
Mission
 Overview   
Details    
Medical   
Watch   
Heart attack  
Stroke    
World health  
Emergency
 Cost effective
 Media 
- Site Map 

SKYCAR   
Details   
Overview  
VTOL   
Airline   
Military   
Transportation
 Images 
- Site Map

Search

Translate 
   8 languages
 

Trends in Acute Ischemic Stroke Trials Through the 20th Century

(Stroke. 2001;32:1349.) ©June  2001 American Heart Association, Inc.
Chelsea S. Kidwell, MD; David S. Liebeskind, MD; Sidney Starkman, MD; Jeffrey L. Saver, MD
From the University of California at Los Angeles (UCLA) Stroke Center (C.S.K., S.S., J.L.S.), Department of Neurology (C.S.K., S.S., J.L.S.), and Department of Emergency Medicine (S.S.), UCLA Medical Center; and Comprehensive Stroke Center and Department of Neurology, University of Pennsylvania, Philadelphia (D.S.L.).

Correspondence to Chelsea S. Kidwell, MD, Department of Neurology, 710 Westwood Plaza, UCLA Medical Center, Los Angeles, CA 90095. E-mail ckidwell@ucla.edu

Skyaid comment: 73,000 patients, 178 trials, over 30 years, concluding that tPA and aspirin work well, yet there has been little change in how strokes are actually treated.

Background and Purpose—The advent of controlled clinical trials revolutionized clinical medicine over the course of the 20th century. The objective of this study was to quantitatively characterize developments in clinical trial methodology over time in the field of acute ischemic stroke.

Methods—All controlled trials targeting acute ischemic stroke with a final report in English were identified through MEDLINE and international trial registries. Data regarding trial design, implementation, and results were extracted. A formal 100-point scale was used to rate trial quality.

Results—A total of 178 controlled acute stroke trials were identified, encompassing 73 949 patients.
83 trials involved neuroprotective agents,
59 rheological/antithrombotic agents,
26 agents with both neuroprotective and rheological/antithrombotic effects
5 a nonpharmacological intervention.
Only 3 trials met conventional criteria for a positive outcome. Between the 1950s and 1990s, the number of trials per decade increased from 3 to 99, and mean trial sample size increased from 38 (median, 26) to 661 (median, 113). During 1980–1999, median time window allowed for enrollment decreased per half decade from 48 to 12 hours. Reported pharmaceutical sponsorship increased substantially over time, from 38% before 1970 to 68% in the 1990s. Trial quality improved substantially from a median score of 12 in the 1950s to 72 in the 1990s.

Conclusions—Accelerating trends in acute stroke controlled trials include growth in number, sample size, and quality, and reduction in entry time window. These changes reflect an increased understanding of the pathophysiology of acute stroke, the imperative for treatment initiation within a critical time window, and more sophisticated trial design.