AMIGOS-2 study

Phase 2

• Conditions: Acute myocardial infarction; Myocardial Ischemia; Vascular Diseases; Myocardial Infarction; Heart Diseases; Cardiovascular Diseases

• Registration Number: RPCEC00000286
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.