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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin | Experimental | Patient receiving Heparin |
|
| Nadroparin | Experimental | Patient receiving nadroparin |
|
| Placebo | Placebo Comparator | Patients receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug |
| ||
| Nadroparin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Nosal, MD, PhD | Contact | +421905764991 | vnosal@gmail.com | |
| Jana Dluha, MD | Contact | +421905514377 | jana.dluha@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Nosal, MD, PhD | Jessenius Faculty of Medicine | Principal Investigator |
| Egon Kurca, MD, PhD, prof | Jessenius Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Clinic Univeristy Hospital in Martin | Recruiting | Martin | 03659 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27646496 | Derived | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D017762 | Nadroparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006495 | Heparin, Low-Molecular-Weight |
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|
| Placebo | Drug |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |