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Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke (Heparinas)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01862978
Recruitment Status : Unknown
Verified August 2013 by Vladimir Nosal, MD, PhD, University Hospital, Martin.
Recruitment status was:  Recruiting
First Posted : May 27, 2013
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):
Vladimir Nosal, MD, PhD, University Hospital, Martin

Brief Summary:

The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours.

Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose.

Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended.

The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose.

All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.

For initiation of treatment will be assessed:

  • Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria
  • Sign the informed consent and patient randomization
  • Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation
  • Women of childbearing age (pregnancy test)
  • History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.).
  • Initial CT examination of the brain
  • EKG
  • USG sections of extracranial carotid and vertebral arteries
  • special hematology factors

If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions.

After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally.

In the interval from 24 to 30 hours of starting treatment the patient will be made:

  • Control CT brain
  • EKG
  • Basic coagulation
  • Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan
  • special hematology factors

    72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index.

Safety endpoints: mortality, adverse side effects, bleeding

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Heparin Drug: Nadroparin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Heparin
Patient receiving Heparin
Drug: Heparin
Drug: Placebo
Experimental: Nadroparin
Patient receiving nadroparin
Drug: Nadroparin
Drug: Placebo
Placebo Comparator: Placebo
Patients receiving placebo
Drug: Heparin
Drug: Nadroparin

Primary Outcome Measures :
  1. Safety of nadroparine or heparin [ Time Frame: DAY 3,7,30,90 ]
    Safety - incidence of intracranial hemorhage

  2. Efficacy of nadroparine or heparin [ Time Frame: DAY 3,7, 30, 90 ]
    Efficacy -level of improvement measured by mRS, and NIHSS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ischemic stroke
  • female or male gender
  • mRS (modified Rankin Scale) 0-1 (min one month before the event)
  • NIHSS ≥ 6 and ≤ 25
  • Age: 18-80 years
  • initiation of therapy in the interval from 4.5 to 24 hours from onset of symptoms of ischemic stroke
  • focal neurological deficit of at least 30 min, which was significantly obviously does not disappear before treatment
  • patient will participate voluntarily and signed informed consent. Informed consent will be obtained from each patient, guardian or close relative
  • patients who are unable to sign, but who are able to understand what means to participate in the study, may give informed consent through eyewitness
  • willingness and ability to comply with the protocol

Exclusion Criteria:

  • intracranial hemorrhage confirmed by CT scan
  • CT image heavy and extensive focal cerebral ischemia
  • lacunar syndrome
  • epileptic seizure at the beginning of ischemic stroke
  • previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis
  • stroke, myocardial infarction, head trauma in the last 3 months
  • tromboctov count below 100 000/mm ³
  • therapeutically uncontrolled blood pressure: systolic blood pressure> 185 mmHg or diastolic blood pressure> 110 mmHg
  • therapeutically uncontrolled blood glucose ˂ 2.77 or> 22.15 mmol / l
  • Known bleeding diathesis, other coagulopathies, severe hepatopathy, severe nephropathy
  • patients receiving oral anticoagulants
  • current or previous life-threatening bleeding
  • major surgery less than 2 weeks ago
  • known malignancy
  • active TB
  • pregnancy
  • allergy to Heparin or Fraxiparine
  • known alcohol abuse and / or drugs
  • active participation in another clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01862978

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Contact: Vladimir Nosal, MD, PhD +421905764991
Contact: Jana Dluha, MD +421905514377

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Neurology Clinic Univeristy Hospital in Martin Recruiting
Martin, Slovakia, 03659
Contact: Jana Dluha, MD    +421905514377   
Principal Investigator: Vladimir Nosal, MD, PhD         
Principal Investigator: Egon Kurca, MD,PhD,prof         
Sub-Investigator: Jana Dluha, MD         
Sub-Investigator: Stefan Sivak, MD,PhD         
Sub-Investigator: Jozef Michalik, MD         
Sub-Investigator: Ema Kantorova, MD,PhD         
Sub-Investigator: Milan Grofik, MD         
Sub-Investigator: Milan Kratky, MD         
Sub-Investigator: Peter Kubisz, MD,DSc,prof         
Sub-Investigator: Peter Chudy, MD,PhD         
Sub-Investigator: Lukas Duraj, Mgr         
Sub-Investigator: Jela Ivankova, RNDr         
Sponsors and Collaborators
University Hospital, Martin
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Principal Investigator: Vladimir Nosal, MD, PhD Jessenius Faculty of Medicine
Study Director: Egon Kurca, MD, PhD, prof Jessenius Faculty of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vladimir Nosal, MD, PhD, Prof.assistant, University Hospital, Martin Identifier: NCT01862978    
Other Study ID Numbers: MTSVKNEUROL001
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Vladimir Nosal, MD, PhD, University Hospital, Martin:
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action