title: The safety and efficacy of Heparin and Nadroparin compared to placebo in acute ischemic stroke - pilot study.
abstract: OBJECTIVE
  This study aimed to compare the efficacy and safety of heparin and nadroparin in order to provide an additional therapeutic option for patients with acute ischemic stroke in, whom systemic thrombolysis was excluded, or thrombectomy could not be performed.
  
  
  METHODS
  We describe a prospective randomized double-blind placebo-controlled pilot study in acute ischemic stroke. The therapeutic window was between 4.5 and 24 h after the onset of stroke. During the first 24 h of treatment, the patients divided into 3 groups received placebo, heparin or nadroparin (in therapeutic doses). During the following 48 h, each patient received nadroparin in the therapeutic dose. 24 h after start of treatment they began taking 100 mg aspirin daily. The primary safety indicator was incidence of complications such as intracerebral or systemic hemorrhage, or death. Efficacy was primarily monitored by the neurological modified Rankin Scale (mRS) at 90 days.
  
  
  RESULTS
  There were no signs of intracerebral or systemic bleeding in the cohort of 87 patients. Two patients died - one (3.7%) in the heparin and one (3.8%) in the placebo group due to causes not connected with the treatment. There was a statistically significant difference in mRS on the 90thday between the heparin and placebo groups (21 (80%) vs 13 (50%), P=0.0350) and between the nadroparin and placebo groups (29 (85%) vs 13 (50%), P=0.0031).
  
  
  CONCLUSIONS
  The results show that the treatment with heparin and nadroparin is safe and effective.
  
  
  BACKGROUND
  Trial is registered in ClinicalTrials.gov: NCT01862978.
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Jana
authors.initials: J
authors.lastname: Dluha
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Stefan
authors.initials: S
authors.lastname: Sivak
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Egon
authors.initials: E
authors.lastname: Kurca
authors.affiliation: Clinic of Urology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Robert
authors.initials: R
authors.lastname: Dusenka
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Klaudia
authors.initials: K
authors.lastname: Kalmarova
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Monika
authors.initials: M
authors.lastname: Turcanova Koprusakova
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Ema
authors.initials: E
authors.lastname: Kantorova
authors.affiliation: Clinic of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava and University Hospital in Martin, Slovak Republic.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Nosal
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D002545:Brain Ischemia / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D017762:Nadroparin / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011446:Prospective Studies; D020521:Stroke / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D017762:Nadroparin; D006493:Heparin
keywords: Key words: acute ischemic stroke; efficacy; heparin; mRS; nadroparin; safety