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

August 14, 2013 updated by: Vladimir Nosal, MD, PhD, University Hospital, Martin

Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Martin, Slovakia, 03659
        • Recruiting
        • Neurology Clinic Univeristy Hospital in Martin
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients receiving placebo
Drug: Heparin
Drug: Nadroparin
Experimental: Heparin
Patient receiving Heparin
Drug: Placebo
Drug: Heparin
Experimental: Nadroparin
Patient receiving nadroparin
Drug: Placebo
Drug: Nadroparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of nadroparine or heparin
Time Frame: DAY 3,7,30,90
Safety - incidence of intracranial hemorhage
DAY 3,7,30,90
Efficacy of nadroparine or heparin
Time Frame: DAY 3,7, 30, 90
Efficacy -level of improvement measured by mRS, and NIHSS
DAY 3,7, 30, 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Martin

Investigators

  • Principal Investigator: Vladimir Nosal, MD, PhD, Jessenius Faculty of Medicine
  • Study Director: Egon Kurca, MD, PhD, prof, Jessenius Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTSVKNEUROL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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