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

NCT01862978 | Unknown Phase 4

• 1 other identifier: MTSVKNEUROL001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Heparin; Nadroparin

Outcome Measures

Primary Outcomes (2)

• Safety of nadroparine or heparin

  Safety - incidence of intracranial hemorhage

  DAY 3,7,30,90

• Efficacy of nadroparine or heparin

  Efficacy -level of improvement measured by mRS, and NIHSS

  DAY 3,7, 30, 90

Study Arms (3)

Heparin

EXPERIMENTAL

Patient receiving Heparin

Drug: Heparin; Drug: Placebo

Nadroparin

EXPERIMENTAL

Patient receiving nadroparin

Drug: Nadroparin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Patients receiving placebo

Drug: Heparin; Drug: Nadroparin

Interventions

Heparin DRUG

Heparin; Placebo

Nadroparin DRUG

Nadroparin; Placebo

Placebo DRUG

Heparin; Nadroparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

Neurology Clinic Univeristy Hospital in Martin

Martin, 03659, Slovakia

RECRUITING

Related Publications (1)

• Dluha J, Sivak S, Kurca E, Dusenka R, Kalmarova K, Turcanova Koprusakova M, Kantorova E, Nosal V. The safety and efficacy of Heparin and Nadroparin compared to placebo in acute ischemic stroke - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Dec;160(4):543-548. doi: 10.5507/bp.2016.042. Epub 2016 Sep 19.

  PMID: 27646496 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Heparin; Nadroparin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight

Study Officials

• Vladimir Nosal, MD, PhD

  Jessenius Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Egon Kurca, MD, PhD, prof

  Jessenius Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Vladimir Nosal, MD, PhD

CONTACT

+421905764991; vnosal@gmail.com

Jana Dluha, MD

CONTACT

+421905514377; jana.dluha@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.assistant

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 27, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

SL (1)