COURAGE Study

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000214
• Date of registration: 27/05/2016
• Prospective Registration: Yes
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana
• Public title: COURAGE Study
• Scientific title: Co-administration of EGF and GHRP-6 in patients with acute cerebral infarction of ischemic etiology.
• Date of first enrolment: 01/09/2016
• Target sample size: 30
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000214-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 1-2

Countries of recruitment

Cuba

Contacts

• Name: Francisco Hernandez Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Francisco Hernandez Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 80 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Nervous System Diseases

Acute cerebral infarction of ischemic etiology

Brain Diseases

Cardiovascular Diseases

Vascular Diseases

Central Nervous System Disease

Cerebral Infarction

Cerebrovascular Disorders

Brain Ischemia

Brain Infarction

Stroke

Intervention(s)

Administration, Intravenous

CIGB-845,
recombinant Epidermal Growth Factor,
GHRP-6

Epidermal Growth Factor

It will be administered CIGB-845 (epidermal growth factor [EGF] combined with two dose levels of growth hormone releasing peptide [GHRP-6]).

Group I (experimental): CIGB-845 (75 µg EGF + 3.5 mg GHRP-6) + conventional treatment. CIGB-845 will be administered intravenously, bolus, slowly for 3 minutes. The first dose will administer at the time of inclusion in the study and, then every 12 hours for 7 days (14 administrations in total).

Group II (experimental): CIGB-845 (75 µg EGF + 7.0 mg GHRP-6) + conventional treatment. CIGB-845 will be administered intravenously, bolus, slowly for 3 minutes. The first dose will administer at the time of inclusion in the study and then every 12 hours for 7 days (14 administrations in total).

Group III (control group): Conventional treatment.

Conventional treatment include: stabilization of the patient (breathing and circulation), correction of water balance and electrolyte disturbances, strict control of vital signs, placing the patient supine with elevated head 30 degrees (treatment of cerebral edema), specific antibiotic therapy, maintaining glycemia below 150 mg / mL, maintain adequate oxygenation of the patient, among other general measures.

Peptides

Growth Hormone-Releasing Hormone

Primary Outcome(s)

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.

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(s)

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

Secondary ID(s)

IG/CIGB-845I/IC/1601

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

Secondary Sponsor(s)

Not applicable