Browsing by keyword "Controlled Clinical Trials as Topic"

Now showing items 1-3 of 3

    • Clinical ethics versus clinical research
      Appelbaum, Paul S.; Lidz, Charles W. (2006-08-04)

    • Determinants of appropriate use of angiotensin-converting enzyme inhibitors after acute myocardial infarction in persons > or = 65 years of age
      Krumholz, Harlan M.; Vaccarino, Viola; Ellerbeck, Edward F.; Kiefe, Catarina I.; Hennen, John; Kresowik, Timothy F.; Gold, Jay A.; Jencks, Stephen F.; Radford, Martha J. (1997-03-01)
      We sought to determine how often angiotensin-converting enzyme (ACE) inhibitors are prescribed as a discharge medication among eligible patients > or = 65 years old with an acute myocardial infarction; to identify patient characteristics associated with the decision to prescribe ACE inhibitors; and to determine the factors associated with the decision to obtain an evaluation of left ventricular function among patients who have no contraindications to ACE inhibitors. We addressed these aims with an observational study of consecutive elderly Medicare beneficiary survivors of an acute myocardial infarction hospitalized in Alabama, Connecticut, Iowa, and Wisconsin between June 1992 and February 1993. Among the 5,453 patients without a contraindication to ACE inhibitors at discharge, 3,528 (65%) had an evaluation of left ventricular function. Of the 1,228 patients without a contraindication to ACE inhibitors who had a left ventricular ejection fraction < or = 40%, 548 (45%) were prescribed the medication at discharge. In a multivariable analysis, an increased prescribed use of ACE inhibitors at discharge was correlated with several factors, including diabetes mellitus, congestive heart failure, ventricular tachycardia, and loop diuretics as a discharge medication. Patients admitted after the publication of the Survival and Ventricular Enlargement (SAVE) trial were significantly more likely to receive ACE inhibitors, although the absolute improvement in utilization was small in the 6 months after the trial results were published. In conclusion, improving the identification of appropriate patients for ACE inhibitors and increasing the prescription of ACE inhibitors for ideal patients may provide an excellent opportunity to improve care.

    • Stroke Therapy Academic Industry Roundtable (STAIR) recommendations for extended window acute stroke therapy trials
      Saver, Jeffrey L.; Albers, Gregory W.; Dunn, Billy; Johnston, Karen C.; Fisher, Marc (2009-05-30)
      The Stroke Therapy Academic Industry Roundtable (STAIR) meetings focus on helping to advance the development of acute stroke therapies. Further extending the time window for acute stroke therapies is an important endeavor for increasing the number of stroke patients who might benefit from treatment. The STAIR group recommends that future extended time window trials initially should focus on selected patient groups most likely to respond to investigational therapies and that penumbral imaging is one tool that may identify such patients. The control group in these trials should receive best locally available medical care; if regulatory approval for intravenous (i.v.) tPA is extended to 4.5 hours, then tPA will become the most appropriate comparator in trials conducted within this time window. In future well-designed extended window clinical trials randomization is appropriate and should not be precluded by using unproven treatment with intraarterial (i.a.) thrombolysis or mechanical devices. For proof of concept, extended time window, phase II trials of i.v. thrombolysis, or mechanical devices in which early recanalization/reperfusion is the primary end point, rescue therapy/bailout treatment with i.a. thrombolysis or devices may be acceptable. Statistical considerations and definitions of successful recanalization/reperfusion are suggested for these trials.