COURAGE Study

Phase 1

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: RPCEC00000214

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: 30

Inclusion Criteria

1. Compliance with the diagnostic criteria (patients of both sexes with a focal neurologic defects caused by disturbances in blood supply to a particular brain area).
2. Age between 18 and 80 years, including both.
3. Time between onset of symptoms and start of administration of CIGB-845 less than 12 hours.
4. Willingness of the patient (or family) through the granting of informed consent (oral). In a second moment (once the patient is stabilized) the investigator must obtain the written consent of the patient, who may freely decide whether to accept or not to continue the investigation.

Exclusion Criteria

1. Coma (Glasgow Coma Scale less than 8).
2. Points in the NIHSS <5 or> 20 scale.
3. When the neurological defect can be explained by a different entity to ICA.
4. Patients with neurological symptoms or signs return to normal before treatment begins.
5. Severe uncontrolled hypertension (systolic> 185 mm Hg or diastolic BP> 110 mm Hg) not descend after treatment.
6. Low blood pressure (systolic <95 mm Hg) unresponsive to standard therapy.
7. Method of installation box with seizures.
8. Patients diagnosed with malignancies.
9. Pregnancy or breastfeeding at the time of inclusion in the study (reported by the patient or family).
10. Mental incapacity obvious to issue consent and act accordingly to the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Adverse Events (AEs). The EA will be measured as -Occurrence of AEs (Yes, No), - AEs Description (name of event), - AEs Intensity (mild, moderate, severe). Measuring time: daily in Week 1 (time management starts CIGB-845) and at months 1, 3 and 6.<br><br>Laboratory test (numerical values of blood chemistry tests: blood count, hematocrit, white blood cell count with differential, ALT, AST, glucose, creatinine, urea, uric acid, alkaline phosphatase, total protein, albumin, bilirubin, cholesterol, coagulogram and electrolytes). Measuring time: at baseline (before the first administration of CIGB-845), at 72 hours, at hospital discharge (7th day) and assessments for the months 1, 3 and 6.

Secondary Outcome Measures

Name	Time	Method
Disability (according to Rankin scale). Measuring time: at hospital discharge and at 3 and 6 months including the patient in the study.<br>Neurologic deficit level (NIHSS scale, National Institute of Heath Stroke Scale). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion.<br>Ability to perform daily activities (according to Barthel index). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion.<br>Infarct volume (Computed Axial Tomography). Measuring time: the inclusion in the study, the 4th and the 7th day after starting treatment.