COURAGE-2 Study

Phase 3

Conditions: Acute cerebral infarction of ischemic etiology
Cerebral Infarction
Brain Infarction
Brain Ischemia
Stroke
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Disease

Registration Number: RPCEC00000300

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 220

Inclusion Criteria

1. Compliance with the diagnostic criteria (patients of both sexes, with a focal neurological defect caused by disturbances of the circulatory supply to a specific brain area, confirmed by computerized axial tomography images).
2. Age between 19 and 80 years, both inclusive.
3. Time between the onset of symptoms and the beginning of the administration of Serendictus less than 12 hours.
4. Voluntariness of the patient (or family member) through the granting of informed consent (oral).

Exclusion Criteria

1. Coma state (Glasgow scale less than 8).
2. Score on the NIHSS scale <5 or > 20.
3. When the neurological defect can be explained by another entity different from the acute cerebral infarction.
4. Patients with neurological symptoms or signs that return to normal before the start of treatment.
5. Severe and uncontrolled arterial hypertension (systolic >200 mmHg or diastolic> 120 mmHg) that does not descend after treatment.
6. Arterial hypotension (systolic <95 mmHg) that does not respond to the usual treatment.
7. How to install the clinical picture with seizures.
8. Patients with basic neurological alterations that could interfere with the functional evaluation process during the course of the study.
9. Patients diagnosed with malignant neoplasms.
10. Pregnancy or lactation at the time of inclusion in the study (referred by the patient or family member).
11. Obvious mental inability to issue consent and act accordingly with the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurological status-disability (It will be evaluated according to the Rankin scale in 0: No symptoms; 1: No significant involvement despite the symptoms, possibility of performing all the activities of daily life; 2: Light disability, can not perform all the activities of daily life, but is able to attend to their bodily needs without help; 3: Moderate disability, requiring some help to satisfy their bodily needs but able to walk without help: 4: Moderately severe disability, inability to wander without help and to attend to their needs. bodily needs without help, 5: severe disability, bedridden, incontinent and with constant need for nursing care and attention). Measurement time: at discharge, and in months 1, 3, 6 and 12.

Secondary Outcome Measures