AMIGOS-2 study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Administration of the growth hormone-releasing peptide in patients with acute myocardial infarction susceptible of thrombolytic therapy

Secondary indentifying numbers:

IG/CIGB-500I/IM/1802

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Antonio

Midle name:

Angel

Last name:

Pelegrin Martinez

Medical Specialty :

1st degree specialist in Cardiology

Affiliation:

General Hospital "Dr. Juan Bruno Zayas Alfonso"

Postal address:

Carretera del Caney s/n esquina 23, Reparto Pastorita

City:

Santiago de Cuba

País:

Cuba

Zip Code:

90100

Telephone:

+53-22641903

Email address:

antoniopelegrin@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Mayabeque, General Hospital "Leopoldito Martinez", Alberto Brito Cruz, 2nd Degree Specialist in Intensive Medicine and Emergencies.

Matanzas, University Hospital "Faustino Perez", Joan Javier Vidal Casal, 1st degree Specialist in Cardiology.

Cienfuegos, University Hospital "Gustavo Aldereguia", Rene Cabrera Nuñez, 1st degree specialist in MGI and in Cardiology.

Villa Clara, University Hospital "Arnaldo Milian", Jose Ignacio Ramirez Gomez, 1st Degree Specialist in MGI and in Cardiology.

Villa Clara, General Hospital "Martires del 9 Abril", Lazaro Mata Cuevas, 1st degree specialist in MGI and in Cardiology.

Sancti Spiritus, General Hospital "Camilo Cienfuegos", Tessa Negrin Valdes, 1st Degree Specialist in Internal Medicine and 2nd Degree in Cardiology.

Ciego de Avila, General Hospital "Antonio Luaces", Mayelin Baro Roja, 1st Degree Specialist in MGI and in Cardiology.

Camaguey, University Hospital "Manuel Ascunce", Angel Esteban Miranda Fragoso, 2nd Degree Specialist in Cardiology.

Holguín, Clinical-Surgical Hospital "Lucia Iñiguez", Ana Beatriz Cobiellas Rodriguez, 1st Degree Specialist in MGI and in Cardiology.

Granma, University Hospital "Carlos M. de Cespedes", Adrian Baez Arias, 1st Degree Specialist in Cardiology.

Granma, Provincial Hospital "Celia Sanchez", Augusto Leandro Berro Zamora, 1st degree Specialist in Cardiology.

Santiago de Cuba, Provincial Hospital "Saturnino Lora", Carlos Manuel Angulo Elers, 2nd Degree Specialist in Cardiology.

Guantanamo, General Hospital "Agostinho Neto", Artemio Cuza Diaz, 2nd Degree Specialist in Cardiology.

Las Tunas, General Hospital "Ernesto Guevara", Yudelquis Ojeda Riquenes, 2nd Degree Specialist in Cardiology.

Havana, Clinical-Surgical Hospital "Joaquin Albarran", Jose Livan Cruz Rodriguez, 1st Degree Specialist in Cardiology.

Research ethics committees:

General Hospital "Juan Bruno Zayas", April 26, 2018.

General Hospital "Leopoldito Martinez", May 08, 2018.

University Hospital "Faustino Perez", May 28, 2018.

University Hospital "Gustavo Aldereguia", April 27, 2018.

University Hospital "Arnaldo Milian", May 02, 2018

General Hospital "Mártires del 9 Abril", April 24, 2018.

General Hospital "Camilo Cienfuegos", April 19, 2018.

General Hospital "Antonio Luaces", April 26, 2018.

University Hospital "Manuel Ascunce", April 27, 2018.

Clinical-Surgical Hospital "Lucia Iñiguez", April 25, 2018.

University Hospital "Carlos M. de Cespedes", April 25, 2018.

Provincial Hospital "Celia Sanchez", April 26, 2018.

Provincial Hospital "Saturnino Lora", May 08, 2018.

General Hospital "Agostinho Neto", April 24, 2018.

General Hospital "Ernesto Guevara", May 02, 2018.

Clinical-Surgical Hospital "Joaquin Albarran", July 09, 2018.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/10/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute myocardial infarction

Health condition(s) code:

Myocardial Infarction

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Cardiovascular Diseases

Intervention(s):

Group I - CIGB-500 (5,0 mg) (Experimental): CIGB-500 peptide (5.0 mg) applied in intravenous bolus, slow, for 3 minutes. Scheme of 20 administrations: one dose every 12 hours for 10 days + thrombolytic therapy with Heberkinasa (1 500 000 IU). Group II - CIGB-500 (10,0 mg) (Experimental): Peptide CIGB-500 (10.0 mg) applied in intravenous bolus, slow, for 3 minutes. Scheme of 20 administrations: one dose every 12 hours for 10 days + thrombolytic therapy with Heberkinasa (1 500 000 IU). Group III - Placebo (Control): Placebo applied intravenous bolus, slow, for 3 minutes. Scheme of 20 administrations: one dose every 12 hours for 10 days + thrombolytic therapy with Heberkinasa (1 500 000 IU).

Intervention code:

Peptides

Thrombolytic Therapy

Streptokinase

Placebos

Intervention keyword:

CIGB-500 peptide

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Global morpho-functional recovery of the left ventricle, in particular, the ejection fraction of the left ventricle (percentage of diastolic ventricular diastolic volume that is ejected into the systemic circulation during a systole: <30% Severe; 30-44% Moderate; 45-54% mild, ≥55% Normal). Measurement time: first 72 hours after the start of treatment, at hospital discharge, and in months 1, 3 and 6.

Key secondary outcomes:

- Mortality (Alive, Dead). Measurement time: at 30 days and at 6 months. - Re-infarction and other complications such as arrhythmia [supraventricular, ventricular, block A / V], shock, cardiac arrest, acute pulmonary edema, heart failure, among others (Yes, No). Measurement time: during the period of execution of the clinical trial (6 months). -Adverse Events (AE)( Occurrence (Yes, No) -Description of the AE (name of the event) -Intensity of the AE (mild, moderate, severe)). Measurement time: daily during hospital admission, and in months 1, 3 and 6. - Vital signs (temperature, blood pressure, heart rate and respiratory rate). Measurement time: daily during hospital admission, and in months 1, 3 and 6. - Electrocardiogram (alterations of the ST segment and in the relation of the QT / QTc interval) (Yes, No, Specify). Measurement time: daily during the hospitalization and in each external evaluation consultation. - Laboratory (numerical values of blood tests and blood chemistry, according to units of measurement). Measurement time: at the beginning, the 5th day, the hospital discharge and in months 1, 3 and 6. - Biological markers of cardiac necrosis and ventricular dysfunction (in heparinized venous blood): troponin T, myoglobin, CK-MB, NT pro BNP (numerical values expressed in corresponding units according to the test). Measurement time: at the beginning, 6 and 24 hours, and daily until the hospital discharge. - Pro-inflammatory markers: IL-6, C-reactive protein (numerical values expressed in corresponding units according to the test). Measurement time: to the 5th day, to the hospital discharge and in months 1, 3 and 6. - Markers of the REDOX system: MDA, H2O2, SOD, etc (numerical values expressed in corresponding units according to the determination). Measurement time: to the 5th day, to the hospital discharge and in months 1, 3 and 6.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1. Compliance with diagnostic confirmation criteria (patients with a clinical diagnosis of acute myocardial infarction of any location, defined as acute necrosis of a territory of the heart muscle, caused by the occlusion of a coronary artery, usually produced by a thrombus formed on a complicated atherosclerotic plaque). 2. Age between 18 and 80 years, both inclusive. 3. Patient presenting his first acute myocardial infarction (AMI). 4. Time not greater than 12 hours between the onset of symptoms and the beginning of the infusion with thrombolytic therapy / administration of the investigational product. 5. Voluntariness of the patient through the granting of informed consent (oral).

Exclusion criteria:

1. Cardiogenic shock as a form of presentation. 2. Active internal bleeding. 3. Neurosurgery or head trauma in the last two months, or intracranial vascular disease (eg, aneurysms, arteriovenous malformations). 4. Recent severe trauma (in the last four weeks). 5. History of CNS haemorrhage, or other recent cerebrovascular event (in the last year). 6. Surgery or biopsy of an organ in the three weeks prior to inclusion in the study. 7. Recent puncture in non-compressible major vessels. 8. Minor trauma with risk (last 10 days), including traumatic or prolonged cardiopulmonary resuscitation. 9. Disorders of hemostasis or use of anticoagulants. 10. Profuse recent gastrointestinal or genitourinary bleeding (in the last three months). 11. Active peptic ulcer. 12. Referred hemorrhagic diabetic retinopathy. 13. Other recent internal bleeding or conditions where there is a risk of major bleeding or would be difficult to manage because of its location. 14. Patients presenting with aortic dissection, septic thrombophlebitis, acute pericarditis or infective endocarditis. 15. Moderate or severe systemic infections that interfere with the patient's evaluation. 16. Severe and uncontrolled arterial hypertension (systolic > 185 mm Hg or diastolic > 110 mm Hg) that does not descend after treatment. 17. Other decompensated chronic diseases (diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 18. Patients diagnosed with malignant neoplasms. 19. History of streptokinase allergy, or any ingredient of the formulations under study. 20. Patients who have been treated with streptokinase in the last six months. 21. Pregnancy or lactation at the time of inclusion (referred by the patient or relative). 22. Obvious mental inability to issue consent and act accordingly with the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

180

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-72085887, +53-72087465

Email :

hernandez.bernal@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-72085887, +53-72087465

Email :

hernandez.bernal@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000286

Date of Registration in Primary Registry:

07/08/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [3]