title: Prophylaxis of thrombotic and embolic events in acute ischemic stroke with the low-molecular-weight heparin certoparin: results of the PROTECT Trial.
abstract: OBJECTIVE
  Patients with stroke are at substantial risk of thromboembolic complications and therefore require antithrombotic prophylaxis. To show the noninferiority of the low-molecular-weight heparin certoparin to unfractionated heparin (UFH) for the prevention of thromboembolic complications, we performed a randomized, double-blind, active-controlled multicenter trial in patients with acute ischemic stroke.
  
  
  METHODS
  Overall, 545 patients were randomized within 24 hours of stroke onset to treatment with certoparin (3000 U anti-Xa OD; n=272) or UFH (5000 U TID; n=273) for 12 to 16 days. Patients with paresis of a leg and an National Institutes of Health Stroke Scale score of 4 to 30 points were included. The primary end point was a composite outcome of proximal deep vein thrombosis, pulmonary embolism, or death related to venous thromboembolism during treatment. Computed tomography was performed at trial entry, after 7 days, and when clinical deterioration occurred.
  
  
  RESULTS
  The per-protocol analysis revealed 17 (7.0%) primary events in the certoparin group compared with 24 (9.7%) in the UFH group, thereby demonstrating noninferiority (P=0.0011), confirmed by intention-to-treat analysis (6.6% versus 8.8%; P=0.008). Major bleeding occurred during treatment in 3 patients allocated to certoparin (1.1%) and 5 patients allocated to UFH (1.8%).
  
  
  CONCLUSIONS
  Certoparin (3000 U anti-Xa OD) is at least as effective and safe as UFH (TID) for the prevention of thromboembolic complications in patients with acute ischemic stroke.
authors.affiliation: University of Essen, Germany. h.diener@uni-essen.de
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Erich B
authors.initials: EB
authors.lastname: Ringelstein
authors.forename: Rüdiger
authors.initials: R
authors.lastname: von Kummer
authors.forename: Helmut
authors.initials: H
authors.lastname: Landgraf
authors.forename: Klaus
authors.initials: K
authors.lastname: Koppenhagen
authors.forename: Job
authors.initials: J
authors.lastname: Harenberg
authors.forename: Ivan
authors.initials: I
authors.lastname: Rektor
authors.forename: Attila
authors.initials: A
authors.lastname: Csányi
authors.forename: Dietmar
authors.initials: D
authors.lastname: Schneider
authors.forename: Jürgen
authors.initials: J
authors.lastname: Klingelhöfer
authors.forename: Joachim
authors.initials: J
authors.lastname: Brom
authors.forename: Gottfried
authors.initials: G
authors.lastname: Weidinger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D006493:Heparin / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D007511:Ischemia / Q000628:therapy; D008875:Middle Aged; D015233:Models, Statistical; D011655:Pulmonary Embolism / Q000188:drug therapy / Q000401:mortality; D012306:Risk; D012720:Severity of Illness Index; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013923:Thromboembolism / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy
chemical_list: D006495:Heparin, Low-Molecular-Weight; D006493:Heparin; C403769:certoparin