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

Acute Ischemic Stroke Clinical Trial

— Heparinas  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01862978
• Other study ID #: MTSVKNEUROL001
• Status: Recruiting
• Phase: Phase 4
• First received: May 20, 2013
• Last updated: August 14, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2013
• Source: University Hospital, Martin
• Contact: Vladimir Nosal, MD, PhD
• Phone: +421905764991
• Email: vnosal[@]gmail.com
• Is FDA regulated: No
• Health authority: Slovak republic: State institute for drug control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• Heparin

• Nadroparin

• Placebo

Locations

Country	Name	City	State
Slovakia	Neurology Clinic Univeristy Hospital in Martin	Martin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Martin

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of nadroparine or heparin	Safety - incidence of intracranial hemorhage	DAY 3,7,30,90	Yes
Primary	Efficacy of nadroparine or heparin	Efficacy -level of improvement measured by mRS, and NIHSS	DAY 3,7, 30, 90	No