Multicenter Randomized Single Blind Study of the Clinical Efficacy and Safety of GNR-060 (JSC "GENERIUM", Russia) Compared to Metalyse (Boehringer Ingelheim Pharma GmbH & Co.KG, Germany) in Patients With ST Elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AO GENERIUM
- 入组人数
- 244
- 试验地点
- 21
- 主要终点
- Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography
研究概览
简要总结
GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST Elevation Myocardial Infarction (STEMI).
详细描述
The trial is designed as a multicenter randomized single blinded study with the centralized blinded outcome assessment. The patients with diagnosed STEMI will be randomly assigned with one of the treatment options within 4 hours after the symptoms onset. The effectiveness of the tested product GNR-060 or reference product Metalyze will be assessed by the coronarography within 24 hours after the thrombolysis with the following PCI in case of ineffectiveness. The patients will then be followed up for survival and cardiac events for 90 days. The safety assessment will also include any related hemorrhagic complication. The pharmacokinetic parameters and immunogenicity will be also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction with elevation of the ST segment of the ECG (at point J) in 2 adjacent leads after no more than 6 hours from the onset of pain (lasting at least 20 minutes) in the chest (at the time of screening):
- •≥ 2.5 mm in male ˂ 40 years, ≥ 2 mm in male ≥ 40 years, or ≥ 1.5 mm in female in leads V2-V3 and/or
- •≥ 1 mm in other leads in the absence of left ventricular hypertrophy or left bundle branch block.
排除标准
- •Diseases accompanied by significant bleeding, currently or within the last 6 months, hemorrhagic diathesis.
- •Current oral anticoagulant therapy with INR > 1.
- •Diseases of the central nervous system at present or in history (neoplasm, aneurysm, surgery on the brain or spinal cord).
- •Severe uncontrolled arterial hypertension.
- •Major surgical interventions, biopsy of a parenchymal organ or significant trauma within the last 2 months (including trauma in combination with AMI at the present time), recent (within the last 3 months) traumatic brain injury.
- •Prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the last 2 weeks.
- •Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (including esophageal varicose veins), active hepatitis.
- •Peptic ulcer of the stomach or duodenum in the acute stage.
- •Chronic kidney disease or other significant kidney disease with a decrease in glomerular filtration rate ≤30 ml / min / 1.73 m
- •Arterial aneurysm or presence of arterial/venous vascular malformation.
- •Neoplasm with an increased risk of bleeding.
- •Acute pericarditis and/or subacute bacterial endocarditis.
- •Acute pancreatitis.
- •Hypersensitivity to the active substance (tenecteplase), gentamicin (residual traces of the manufacturing process) or any excipient.
- •Hemorrhagic stroke or stroke of unknown etiology at present or in history.
- •Intracranial (including subarachnoid) hemorrhage at present or in history.
- •Ischemic stroke or transient ischemic attack (TIA) within the last 6 months.
- •Recent bleeding from the gastrointestinal or genitourinary tract or childbirth (within the last 10 days).
- •A recent (before 24 hours) puncture of an incompressible blood vessel (eg, subclavian or jugular vein).
- •Congenital and hereditary hemorrhagic coagulopathy (hemophilia, etc.) in history.
- •Pregnancy or breastfeeding.
- •Body mass index (BMI) less than 18.5 or more than 40 kg/m
- •Participation in another clinical trial currently or within 30 days prior to screening; use of any investigational drug within 30 days or 5 half-lives prior to screening.
结局指标
主要结局
Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography
时间窗: up to 24 hours
TIMI Grade 3 coronary blood flow after the trombolisis
次要结局
- Frequency of the complete+partial myocardial reperfusion based on the independent assessment of coronary angiography(up to 24 hours)
- Changes in troponin T and creatine kinase MB levels(7 days)
- Frequency of myocardial reperfusion based on ECG data(after 90 minutes)
- 90-Day mortality(90 days)
- 30-Day and 90-Day cardiovascular mortality(30 and 90 days)
- Frequency of the postinfarction complications(up to 30 days)
- Frequency of the combined events "cardiovascular death + recurrent myocardial infarction + stroke" and "cardiovascular death + recurrent myocardial infarction + stroke + heart failure"(30 days)