RPCEC00000286尚未招募2 期
Administration of the growth hormone-releasing peptide in patients with acute myocardial infarction susceptible of thrombolytic therapy
Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 180 人开始时间: 2018年8月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
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