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

Sponsor

University Hospital, Martin (Other)

Overall Status

Unknown status

CT.gov ID

NCT01862978

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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

Anticipated 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 1, 2013

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Dec 1, 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

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

Safety of nadroparine or heparin [DAY 3,7,30,90]
Safety - incidence of intracranial hemorhage
Efficacy of nadroparine or heparin [DAY 3,7, 30, 90]
Efficacy -level of improvement measured by mRS, and NIHSS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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