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

Recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Nadroparin (Fraxiparine┬«)Drug
    ARM 1: Kind: Experimental
    Label: Nadroparin
    ARM 2: Kind: Experimental
    Label: Placebo
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Heparin
    ARM 2: Kind: Experimental
    Label: Nadroparin
  • Heparin Drug
    ARM 1: Kind: Experimental
    Label: Heparin
    ARM 2: Kind: Experimental
    Label: Placebo

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety of nadroparine or heparin DAY 3,7,30,90 Yes
Primary Efficacy of nadroparine or heparin DAY 3,7, 30, 90 No

Sponsors