Viewing Study NCT05978791



Ignite Creation Date: 2024-05-06 @ 7:20 PM
Last Modification Date: 2024-10-26 @ 3:05 PM
Study NCT ID: NCT05978791
Status: RECRUITING
Last Update Posted: 2023-10-12
First Post: 2023-07-31

Brief Title: Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human Arterial Thrombus
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Organization: The First Affiliated Hospital with Nanjing Medical University

Study Overview

Official Title: Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human Arterial Thrombus
Status: RECRUITING
Status Verified Date: 2023-10
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: Recombinant staphylokinase r-SAK is a third-generation thrombolytic agent produced by genetic engineering technology in 1985 which has better thrombolytic effect than streptokinase SK and urokinase UK It has similar biological properties to natural SAK is highly selective to fibrin does not activate systemic fibrinolysis and can dissolve clots in a short period of time without significantly increasing the risk of bleeding especially for platelet-rich arterial clots Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy Inspired by the natural affinity of platelets PLT in hemostasis and pathological thrombosis we have developed a thrombus targeting nanocarrier which is a platelet membrane cloaked r-SAKPLT-SAKand compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus aiming to further improve the thrombolytic effectiveness of r-SAK
Detailed Description: Currently the most important treatment for thrombus and related cardiovascular diseases is prevention but in the case of long-term thrombosis the main treatment options include balloon catheters surgical removal of embolus thrombolytic therapy and other related operations Considering the cost of surgical treatment and its damage to the body thrombolytic therapy has become one of the most effective ways to achieve rapid thrombus clearance and recanalization of blocked blood vessels in thrombotic diseases

Recombinant staphylokinase r-SAK is a third-generation thrombolytic agent produced by genetic engineering technology in 1985 which has better thrombolytic effect than streptokinase SK and urokinase UK It has similar biological properties to natural SAK is highly selective to fibrin does not activate systemic fibrinolysis and can dissolve clots in a short period of time without significantly increasing the risk of bleeding especially for platelet-rich arterial clots Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy Inspired by the natural affinity of platelets PLT in hemostasis and pathological thrombosis we have developed a thrombus targeting nanocarrier which is a platelet membrane cloaked r-SAKPLT-SAKand compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus aiming to further improve the thrombolytic effectiveness of r-SAK

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