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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital, Martin
Sponsor:
Information provided by (Responsible Party):
Vladimir Nosal, MD, PhD, University Hospital, Martin
ClinicalTrials.gov Identifier:
NCT01862978
First received: May 20, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
Drug: Heparin
Drug: Nadroparin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by University Hospital, Martin:

Primary Outcome Measures:
  • Safety of nadroparine or heparin [ Time Frame: DAY 3,7,30,90 ] [ Designated as safety issue: Yes ]
    Safety - incidence of intracranial hemorhage

  • Efficacy of nadroparine or heparin [ Time Frame: DAY 3,7, 30, 90 ] [ Designated as safety issue: No ]
    Efficacy -level of improvement measured by mRS, and NIHSS


Estimated Enrollment: 150
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862978

Contacts
Contact: Vladimir Nosal, MD, PhD +421905764991 vnosal@gmail.com
Contact: Jana Dluha, MD +421905514377 jana.dluha@gmail.com

Locations
Slovakia
Neurology Clinic Univeristy Hospital in Martin Recruiting
Martin, Slovakia, 03659
Contact: Jana Dluha, MD    +421905514377    jana.dluha@gmail.com   
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
Investigators
Principal Investigator: Vladimir Nosal, MD, PhD Jessenius Faculty of Medicine
Study Director: Egon Kurca, MD, PhD, prof Jessenius Faculty of Medicine
  More Information

No publications provided

Responsible Party: Vladimir Nosal, MD, PhD, Prof.assistant, University Hospital, Martin
ClinicalTrials.gov Identifier: NCT01862978     History of Changes
Other Study ID Numbers: MTSVKNEUROL001
Study First Received: May 20, 2013
Last Updated: August 14, 2013
Health Authority: Slovak republic: State institute for drug control

Keywords provided by University Hospital, Martin:
Stroke
Heparin
Nadroparin

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Calcium heparin
Heparin
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014