Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS)

• Anthony J. Furlan

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Dirk Eyding

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Gregory W. Albers

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Yasir Al-Rawi

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Kennedy R. Lees

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Howard A. Rowley

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Christian Sachara

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Mariola Soehngen

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Steven Warach

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

• Werner Hacke

  From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.),...

Bibliographic Information

Other Title

• Evidence of Safety and Efficacy 3 to 9 Hours After Stroke Onset

Abstract

Background and Purpose— Desmoteplase is a novel plasminogen activator with favorable features in vitro compared with available agents. This study evaluated safety and efficacy of intravenous (IV) desmoteplase in patients with perfusion/diffusion mismatch on MRI 3 to 9 hours after onset of acute ischemic stroke. Methods— DEDAS was a placebo-controlled, double-blind, randomized, dose-escalation study investigating doses of 90 μg/kg and 125 μg/kg desmoteplase. Eligibility criteria included baseline National Institute of Health Stroke Scale (NIHSS) scores of 4 to 20 and MRI evidence of perfusion/diffusion mismatch. The safety end point was the rate of symptomatic intracranial hemorrhage. Primary efficacy co-end points were MRI reperfusion 4 to 8 hours after treatment and good clinical outcome at 90 days. The primary analyses were intent-to-treat. Before unblinding, a target population, excluding patients violating specific MRI criteria, was defined. Results— Thirty-seven patients were randomized and received treatment (intent-to-treat; placebo: n=8; 90 μg/kg: n=14; 125 μg/kg: n=15). No symptomatic intracranial hemorrhage occurred. Reperfusion was achieved in 37.5% (95% CI [8.5; 75.5]) of placebo patients, 18.2% (2.3; 51.8) of patients treated with 90 μg/kg desmoteplase, and 53.3% (26.6; 78.7) of patients treated with 125 μg/kg desmoteplase. Good clinical outcome at 90 days occurred in 25.0% (3.2; 65.1) treated with placebo, 28.6% (8.4; 58.1) treated with 90 μg/kg desmoteplase and 60.0% (32.3; 83.7) treated with 125 μg/kg desmoteplase. In the target population (n=25), the difference compared with placebo increased and was statistically significant for good clinical outcome with 125 μg/kg desmoteplase ( P =0.022). Conclusions— Treatment with IV desmoteplase 3 to 9 hours after ischemic stroke onset appears safe. At a dose of 125 μg/kg desmoteplase appeared to improve clinical outcome, especially in patients fulfilling all MRI criteria. The results of DEDAS generally support the results of its predecessor study, Desmoteplase in Acute Ischemic Stroke (DIAS).

Journal

• Stroke

  Stroke 37 (5), 1227-1231, 2006-05

  Ovid Technologies (Wolters Kluwer Health)

Keywords

• Advanced and Specialized Nursing
• Cardiology and Cardiovascular Medicine
• Neurology (clinical)

Details

• CRID: 1361699994383686400
• NII Article ID: 30022681609
• DOI: 10.1161/01.str.0000217403.66996.6d
• ISSN: 15244628
• ISSN: 00392499
• Web Site: https://www.ahajournals.org/doi/full/10.1161/01.STR.0000217403.66996.6d
• Data Source:
  • Crossref
  • CiNii Articles