Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke (Heparinas)
|ClinicalTrials.gov Identifier: NCT01862978|
Recruitment Status : Unknown
Verified August 2013 by Vladimir Nosal, MD, PhD, University Hospital, Martin.
Recruitment status was: Recruiting
First Posted : May 27, 2013
Last Update Posted : August 15, 2013
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
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Patient receiving Heparin
|Drug: Heparin Drug: Placebo|
Patient receiving nadroparin
|Drug: Nadroparin Drug: Placebo|
Placebo Comparator: Placebo
Patients receiving placebo
|Drug: Heparin Drug: Nadroparin|
- Safety of nadroparine or heparin [ Time Frame: DAY 3,7,30,90 ]Safety - incidence of intracranial hemorhage
- Efficacy of nadroparine or heparin [ Time Frame: DAY 3,7, 30, 90 ]Efficacy -level of improvement measured by mRS, and NIHSS
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862978
|Contact: Vladimir Nosal, MD, PhDfirstname.lastname@example.org|
|Contact: Jana Dluha, MDemail@example.com|
|Neurology Clinic Univeristy Hospital in Martin||Recruiting|
|Martin, Slovakia, 03659|
|Contact: Jana Dluha, MD +421905514377 firstname.lastname@example.org|
|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|
|Principal Investigator:||Vladimir Nosal, MD, PhD||Jessenius Faculty of Medicine|
|Study Director:||Egon Kurca, MD, PhD, prof||Jessenius Faculty of Medicine|