NCT05978791

Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human Arterial Thrombus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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-SAK（PLT-SAK）and 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-SAK（PLT-SAK）and 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.

Conditions

• Arterial Thrombosis

Interventions

Type	Name	Description
PROCEDURE	collection of venous blood or arterial blood	1. Partial CAD patients were collected 20 mL arterial blood samples 12 hours after the last intake of 100mg aspirin and 2 hours after intake of 90mg ticagrelor. The blood samples were divided into 2 mL centrifuge tubes, with each containing 1.0 mL (for preparation of blood clots). 2. Partial CAD patients were collected 40 mL blood samples into sodium citrate anticoagulant tubes 12 hours after the last intake of 100mg aspirin and 2 hours after intake of 90mg ticagrelor (for preparation of platelet-poor plasma, PPP). 3. Healthy volunteer (group 1) collected 40 mL blood samples into sodium citrate anticoagulant tubes (for preparation of PPP). 4. Healthy volunteer (group 2) collected 9 mL venous blood samples (for platelet aggregation assay).

Timeline

• Start date: 2023-10-11
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-08-07
• Last updated: 2023-10-12

Locations

1 site across 1 country: China