An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 14
- 主要终点
- All-cause mortality
研究概览
简要总结
The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.
详细描述
In November 2023 a multicenter, open-label, randomized non-inferiority trial of the efficacy and safety of the non-immunogenic staphylokinase (Fortelyzin®) compared with alteplase (Actilyse®) in patients with massive pulmonary embolism (FORPE) has been completed (NCT04688320).
FORPE trial is the first report of the non-immunogenic staphylokinase usage in patients with massive pulmonary embolism accompanied by unstable haemodynamics. Non-immunogenic staphylokinase was found to be non-inferior to alteplase (p=1.00). Non-immunogenic staphylokinase had high safety profile and did not cause the major bleeding. No cases of haemorrhagic stroke or major bleeding were recorded in the non-immunogenic staphylokinase group, whereas there were five cases (5%) of BARC type 3+5 bleedings in the alteplase group (p=0.026). All major bleedings and fatal intracranial haemorrhage in the alteplase group were registered only in 60 years old patients.
The unique mechanism of action of non-immunogenic staphylokinase allows it to be used in a single dose of 15 mg, regardless of the patient's body weight. Non-immunogenic staphylokinase is easy to administer with a rapid single bolus that makes it convenient for use in emergency medicine.
The indication "massive pulmonary embolism" is included in the Instructions for medical use of the non-immunogenic staphylokinase. In routine clinical practice, the non-immunogenic staphylokinase is used for massive pulmonary embolism treatment since 2024.
The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years and older.
- •Verified diagnosis of massive pulmonary embolism (using computer tomography)
- •Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
- •The time from the symptoms onset is no more than 14 days.
- •Thrombolysis with the non-immunogenic staphylokinase, 15 mg as a single intravenous bolus.
排除标准
- •Increased risk of bleeding:
- •extensive bleeding at present or within the previous 6 months;
- •intracranial (including subarachnoid) hemorrhage at present or in history;
- •hemorrhagic stroke within the last 6 months;
- •a history of diseases of the central nervous system (including neoplasms, aneurysms);
- •intracranial or spinal surgical interventions within the last 2 months;
- •major surgery or major trauma within the previous 4 weeks;
- •recent puncture of an incompressible blood vessel (eg, subclavian or jugular vein);
- •severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
- •confirmed gastric or duodenal ulcer within the last 3 months;
- •neoplasm with an increased risk of bleeding;
- •simultaneous administration of Dabigatran without prior administration of idarucizumab;
- •arterial aneurysms, developmental defects of arteries / veins;
- •acute pancreatitis;
- •bacterial endocarditis, pericarditis;
- •suspicion of aortic dissecting aneurysm;
- •any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.
- •Lactation, pregnancy.
- •Known hypersensitivity to the non-immunogenic recombinant staphylokinase.
研究组 & 干预措施
Non-immunogenic staphylokinase
Drug: non-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®
干预措施: Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin® (Drug)
结局指标
主要结局
All-cause mortality
时间窗: day 7 after drug administration
The number of death from any causes during hospitalization
All-cause mortality
时间窗: day 7 after drug administration
The number of death from any causes during admission
次要结局
- All-cause mortality(day 30 after drug administration)
- Haemodynamic Collapse(day 30 after drug administration)
- Recurrent Pulmonary Embolism(day 30 after drug administration)
- Pulmonary Artery Systolic Pressure Measures(baseline and day 2 after drug administration)
- All-cause mortality(day 30 after drug administration)
- Haemodynamic Collapse(day 30 after drug administration)
- Recurrent Pulmonary Embolism(day 30 after drug administration)
- Pulmonary Artery Systolic Pressure Measures(baseline and day 2 after drug administration)