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Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism
The main goal of treating massive PE is to save the lives of patients by restoring pulmonary perfusion, preventing the development of chronic postembolic pulmonary hypertension and recurrent PE. According to data of clinical trials, with timely initiation of therapy for massive pulmonary embolism, mortality can be significantly reduced.
Recombinant protein which contains aminoacid sequence of staphylokinase - Fortelizin® (the active substance is Forteplase). It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.
The main objectives of the study: to assess the efficacy, safety and possible adverse events of the drug Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the drug Alteplase® in patients with massive pulmonary embolism.
Study Design. Multicenter, open-label, randomized, comparative clinical study of non-inferiority study of efficacy and safety in parallel groups. At clinical centers, patients will be equally randomly distributed by the "envelope" method into two groups of 155 patients each (310 people in total, including 10% of those who may have dropped out)to receive Recombinant Non-immunogenic Staphylokinase or Alteplase®.
The drugs will be administered after the signed informed consent. Recombinant Non-immunogenic Staphylokinase will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use.
Patients will be monitored for 30 days from the moment of randomization: in the intensive care unit up to 7 days, after it in the hospital until discharge - an average of 14 days and an outpatient visits on the 30th day. The recruitment of patients for the study will be competitive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant nonimmunogenic staphylokinase | Experimental | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. |
|
| Alteplase | Experimental | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant nonimmunogenic staphylokinase | Drug | 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death From All Causes | The efficacy is evaluated in terms of the number of deaths from all causes | within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) | The efficacy is evaluated in terms of systolic pulmonary artery pressure values | baseline and day 1, 7, 14 after randomisation |
| Haemodynamic Collapse |
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Inclusion Criteria:
Men and women aged 18 and over
Verified diagnosis of massive PE (using MSCT with PA contrast)
Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
Availability of signed and dated informed consent of the patient to participate in the study.
Exclusion Criteria:
• Increased risk of bleeding:
Lactation, pregnancy
Known hypersensitivity to Alteplase, Fortelizin.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander I Kirienko, MD, PhD | Pirogov Russian National Research Medical University | Principal Investigator |
| Sergey S Markin, MD, PhD | Supergene, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| V.F. Dolgopolov Vyselki Central District Hospital | Vyselki | Krasnodarskiy Kray | 353100 | Russia | ||
| Sergiyev Posad Regional Clinical Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40391253 | Derived | Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Nonimmunogenic Staphylokinase | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2021 |
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At clinical centers, patients will be equally randomly distributed by the "envelope method" into two groups to receive Fortelizin® or Alteplase®.
The drugs will be administered after the signed informed consent. Fortelizin® will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use. All patients will be examination for 30 days.
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All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilize) by using "envelope method" of randomization.
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|
| Alteplase | Drug | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. |
|
|
The efficacy is evaluated in terms of the number of haemodynamic collapse
| within 7 days |
| Recurrent Pulmonary Embolism (PE) | The efficacy is evaluated in terms of the number of recurrent PE | within 7 days |
| Death From PE | The efficacy is evaluated in terms of the number of deaths from PE | within 30 days |
| Death From All Causes | The efficacy is evaluated in terms of the number of deaths from all causes | within 30 days |
| Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days | The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes | within 30 days |
| Safety Endpoint - Haemorrhagic Stroke | The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation | within 7 days |
| Safety Endpoint - BARC Type 3+5 Bleeding | The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents. Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision. Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation. | within 30 days |
| Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs) | The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) | within 30 days |
| Sergiyev Posad |
| Moscow Oblast |
| 141301 |
| Russia |
| Belgorod Regional Clinical Hospital of St. Joseph | Belgorod | 308007 | Russia |
| Kuzbass Cardiology center | Kemerovo | 650002 | Russia |
| Krasnoyarsk Regional Clinical Hospital | Krasnoyarsk | 660022 | Russia |
| Kursk Regional Clinical Hospital | Kursk | 305007 | Russia |
| D.D. Pletnev City Clinical Hospital | Moscow | 105077 | Russia |
| I.V. Davydovskii City Clinical Hospital | Moscow | 109240 | Russia |
| S.S. Yudin City Clinical Hospital | Moscow | 115446 | Russia |
| V.V. Vinogradov City Clinical Hospital | Moscow | 117292 | Russia |
| V.V. Veresaev City Clinical Hospital | Moscow | 127644 | Russia |
| N.V. Sklifosovsky Research Institute for Emergency Medicine | Moscow | 129090 | Russia |
| S.P. Botkin City Clinical Hospital | Moscow | Russia |
| Murmansk Regional Clinical Hospital | Murmansk | 183047 | Russia |
| N.N. Burdenko Penza Regional Clinical hospital | Penza | 440026 | Russia |
| G.A. Zakharyin Clinical hospital №6 | Penza | 440071 | Russia |
| Saint Petersburg "Mariinskaya" City Hospital | Saint Petersburg | 191014 | Russia |
| Holy Martyr Elizabeth Saint Petersburg City Hospital | Saint Petersburg | 195257 | Russia |
| V.P. Polyakov Samara Regional Clinical Cardiology Dispensary | Samara | 443070 | Russia |
| Saratov Regional Clinical Cardiology Dispensary | Saratov | 410039 | Russia |
| Tver Regional Clinical Hospital | Tver' | 170036 | Russia |
| City Clinical hospital №4 | Vladimir | 600009 | Russia |
| City Clinical Hospital of Emergency №25 | Volgograd | 400138 | Russia |
| FG001 | Alteplase | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. |
| COMPLETED |
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| NOT COMPLETED |
|
310 patients were randomly assigned to receive either non-immunogenic staphylokinase (n=155) or alteplase (n=155)
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Nonimmunogenic Staphylokinase | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds |
| BG001 | Alteplase | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body mass index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Pulmonary Embolism Severity Index (PESI) score | Pulmonary embolism severity index (PESI). PESI evaluates the patient's age and mortality risk factors. The minimum score on the PESI scale = the patient's age, the maximum = the patient's age + 230 points. If total PESI score is ≤ 65, patient has a very low risk of mortality; 66-85 score - a low risk of mortality; 86-105 score - an intermediate risk of mortality; 106-125 score - a high risk of mortality; if PESI score > 125, patient has a very high risk of mortality. | Median | Inter-Quartile Range | score |
| ||||||||||||||||
| PESI class V patients | Patients, who have pulmonary embolism severity index (PESI) > 125 score, considered as a class V, with a very high risk of mortality | Count of Participants | Participants |
| |||||||||||||||||
| Onset to treatment time | Median | Inter-Quartile Range | h |
| |||||||||||||||||
| Qanadli index | To quantify the degree of pulmonary artery obstruction by CTPA, the Qanadli index was calculated, where 0 points means no obstruction, 40 points means complete occlusion of all branches of the pulmonary artery. The percentage (%) of pulmonary artery obstruction was calculated by dividing the patient's score by the maximum score (40) and and multiplying the result by 100. | Mean | Standard Deviation | % of pulmonary artery obstruction |
| ||||||||||||||||
| Right ventricle end-diastolic diameter | Median | Inter-Quartile Range | mm |
| |||||||||||||||||
| Right ventricular/lLeft ventricular end-diastolic diameter | Ratio of right ventricular (RV) end-diastolic diameter to left ventricular (LV) end-diastolic diameter | Median | Inter-Quartile Range | ratio |
| ||||||||||||||||
| Baseline systolic blood pressure | Median | Inter-Quartile Range | mm Hg |
| |||||||||||||||||
| Baseline diastolic blood pressure | Median | Inter-Quartile Range | mm Hg |
| |||||||||||||||||
| Baseline heart rate | Median | Inter-Quartile Range | beats per min |
| |||||||||||||||||
| Baseline respiratory rate | Median | Inter-Quartile Range | breaths per min |
| |||||||||||||||||
| Baseline SpO2 | Median | Inter-Quartile Range | % |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Death From All Causes | The efficacy is evaluated in terms of the number of deaths from all causes | in the per-protocol population | Posted | Count of Participants | Participants | within 7 days |
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| Secondary | Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) | The efficacy is evaluated in terms of systolic pulmonary artery pressure values | The efficacy is evaluated in terms of decreasing of pulmonary artery systolic pressure (PASP) values on baseline and day 1, 7, 14 after randomisation in the per-protocol population | Posted | Median | Inter-Quartile Range | mm Hg | baseline and day 1, 7, 14 after randomisation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Haemodynamic Collapse | The efficacy is evaluated in terms of the number of haemodynamic collapse | The efficacy is evaluated in terms of the number of haemodynamic collapse in the per-protocol population | Posted | Number | events | within 7 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrent Pulmonary Embolism (PE) | The efficacy is evaluated in terms of the number of recurrent PE | The efficacy is evaluated in terms of the number of recurrent PE in the per-protocol population | Posted | Number | events | within 7 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death From PE | The efficacy is evaluated in terms of the number of deaths from PE | The efficacy is evaluated in terms of the number of deaths from PE in the per-protocol population | Posted | Count of Participants | Participants | within 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death From All Causes | The efficacy is evaluated in terms of the number of deaths from all causes | The efficacy is evaluated in terms of the number of deaths from all causes in the per-protocol population | Posted | Count of Participants | Participants | within 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days | The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes | The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes within 30 days in the per-protocol population | Posted | Number | events | within 30 days |
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| Secondary | Safety Endpoint - Haemorrhagic Stroke | The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation | The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation in the per-protocol population | Posted | Number | events | within 7 days |
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| Secondary | Safety Endpoint - BARC Type 3+5 Bleeding | The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents. Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision. Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation. | The safety is evaluated in terms of the number of BARC type 3+5 bleeding within 30 days in the per-protocol population | Posted | Number | events | within 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs) | The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) | The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) in the per-protocol population | Posted | Number | events | within 30 days |
|
30 days.
Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Nonimmunogenic Staphylokinase | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds | 6 | 145 | 9 | 145 | 72 | 155 |
| EG001 | Alteplase | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. | 4 | 146 | 17 | 146 | 86 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent PE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Haemodynamic collapse | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Cerebral oedema | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Brainstem damage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Haematoma of the thigh | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Death from all causes | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | 30 days |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sergey Markin | LLC "SuperGene" | (495) 287-98-07 | +7 | info@supergene.ru |
| Oct 25, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2018 | Oct 25, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
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