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

• ClinicalTrials.gov Identifier: NCT01862978
• Recruitment Status: Unknown
• First Posted: May 27, 2013
• Last Update Posted: August 15, 2013
• Sponsor: University Hospital, Martin
• Information provided by (Responsible Party): Vladimir Nosal, MD, PhD, University Hospital, Martin

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Vladimir Nosal, MD, PhD, Prof.assistant, University Hospital, Martin
• ClinicalTrials.gov Identifier: NCT01862978
• Other Study ID Numbers: MTSVKNEUROL001
• First Posted: May 27, 2013
• Last Update Posted: August 15, 2013
• Last Verified: August 2013

Keywords provided by Vladimir Nosal, MD, PhD, University Hospital, Martin:

Stroke; Heparin; Nadroparin

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Heparin; Nadroparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action