PMID- 16306456
OWN - NLM
STAT- MEDLINE
DCOM- 20060221
LR  - 20220408
IS  - 1524-4628 (Electronic)
IS  - 0039-2499 (Linking)
VI  - 37
IP  - 1
DP  - 2006 Jan
TI  - Prophylaxis of thrombotic and embolic events in acute ischemic stroke with the 
      low-molecular-weight heparin certoparin: results of the PROTECT Trial.
PG  - 139-44
AB  - BACKGROUND AND PURPOSE: 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.
FAU - Diener, Hans-Christoph
AU  - Diener HC
AD  - University of Essen, Germany. h.diener@uni-essen.de
FAU - Ringelstein, Erich B
AU  - Ringelstein EB
FAU - von Kummer, Rudiger
AU  - von Kummer R
FAU - Landgraf, Helmut
AU  - Landgraf H
FAU - Koppenhagen, Klaus
AU  - Koppenhagen K
FAU - Harenberg, Job
AU  - Harenberg J
FAU - Rektor, Ivan
AU  - Rektor I
FAU - Csanyi, Attila
AU  - Csanyi A
FAU - Schneider, Dietmar
AU  - Schneider D
FAU - Klingelhofer, Jurgen
AU  - Klingelhofer J
FAU - Brom, Joachim
AU  - Brom J
FAU - Weidinger, Gottfried
AU  - Weidinger G
CN  - PROTECT Trial Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20051123
PL  - United States
TA  - Stroke
JT  - Stroke
JID - 0235266
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Heparin/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/*therapeutic use
MH  - Humans
MH  - Ischemia/therapy
MH  - Middle Aged
MH  - Models, Statistical
MH  - Pulmonary Embolism/drug therapy/mortality
MH  - Risk
MH  - Severity of Illness Index
MH  - Stroke/*drug therapy/mortality/pathology
MH  - Thromboembolism/*drug therapy/mortality/pathology
MH  - Time Factors
MH  - Tomography, X-Ray Computed
MH  - Treatment Outcome
MH  - Venous Thrombosis/drug therapy
EDAT- 2005/11/25 09:00
MHDA- 2006/02/24 09:00
CRDT- 2005/11/25 09:00
PHST- 2005/11/25 09:00 [pubmed]
PHST- 2006/02/24 09:00 [medline]
PHST- 2005/11/25 09:00 [entrez]
AID - 01.STR.0000195182.67656.ee [pii]
AID - 10.1161/01.STR.0000195182.67656.ee [doi]
PST - ppublish
SO  - Stroke. 2006 Jan;37(1):139-44. doi: 10.1161/01.STR.0000195182.67656.ee. Epub 2005 
      Nov 23.