Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362746
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-02
Brief Title:
Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Sponsor:
Supergene LLC
Organization:
Supergene LLC
Study Overview
Official Title:
Multicenter Double-blind Randomized Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism FORPE-2
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism PE
Detailed Description:
For patients with massive PE thrombolysis can be life-saving and may reduce a pulmonary obstruction pulmonary hypertension and right ventricle dysfunction Efficacy of the thrombolytic therapy has been proven in patients with high-risk pulmonary embolism accompanied by shock or systemic hypotension However the question of whether thrombolytic therapy can improve the clinical outcome of hemodynamically stable patients ie with PE of intermediate high-risk still remains controversial
In PEITHO trial tenecteplase administered as a single bolus at a dose of 30-50 mg depending on body weight was compared with a placebo in patients with intermediate high-risk PE with right ventricular dysfunction Efficacy of tenecteplase was combined with a significant 63 risk of hemorrhagic stroke which did not allow tenecteplase to be included in the list of recommended thrombolytics for PE treatment
PEITHO-3 trial has now begun in which patients with intermediate high-risk PE are given a reduced dose of alteplase 06 mgkg infusion with the total dose not exceeding 50 mg compared with placebo
Staphylokinase is a thrombolytic agent with high biological activity Amino acid substitutions - including Lys74Ala Glu75Ala and Arg77Ala - resulted in a more than 200-times reduction in titres of neutralising antistaphylokinase IgGs in patients with ST-elevation myocardial infarction In FORPE trial NCT04688320 non-immunogenic recombinant staphylokinase was non-inferior as compared with alteplase in patients with high-risk massive PE
The main objectives of this study to assess the efficacy safety and possible adverse events of the non-immunogenic recombinant staphylokinase with its single bolus administration in normotensive patients with intermediate high-risk PE in comparison with placebo
In PEITHO trial tenecteplase administered as a single bolus at a dose of 30-50 mg depending on body weight was compared with a placebo in patients with intermediate high-risk PE with right ventricular dysfunction Efficacy of tenecteplase was combined with a significant 63 risk of hemorrhagic stroke which did not allow tenecteplase to be included in the list of recommended thrombolytics for PE treatment
PEITHO-3 trial has now begun in which patients with intermediate high-risk PE are given a reduced dose of alteplase 06 mgkg infusion with the total dose not exceeding 50 mg compared with placebo
Staphylokinase is a thrombolytic agent with high biological activity Amino acid substitutions - including Lys74Ala Glu75Ala and Arg77Ala - resulted in a more than 200-times reduction in titres of neutralising antistaphylokinase IgGs in patients with ST-elevation myocardial infarction In FORPE trial NCT04688320 non-immunogenic recombinant staphylokinase was non-inferior as compared with alteplase in patients with high-risk massive PE
The main objectives of this study to assess the efficacy safety and possible adverse events of the non-immunogenic recombinant staphylokinase with its single bolus administration in normotensive patients with intermediate high-risk PE in comparison with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None