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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05978791
Collaborator
(none)
10
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

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-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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: collection of venous blood or arterial blood

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study on the Thrombolytic Effect of Platelet Membrane Cloaked Recombinant Staphylokinase on Human Arterial Thrombus
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Hospitalized patients with suspected coronary artery disease

aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours

Procedure: collection of venous blood or arterial blood
At 2h after the last administration of ticagrelor 90mg in patients scheduled for coronary angiography (CAG), about 40mL blood samples were collected before operation and divided into 2mL round bottom frozen tubes, 1mL/tube to prepare blood clots. At 2h after the last administration of ticagrelor 90mg in patients scheduled for CAG, about 40mL blood samples were collected before operation and put into the citrate anticoagulant tube for platelet-poor plasma(PPP) extraction. 9mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for platelet aggregation function test. 40mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for PPP extraction.
healthy volunteers

Procedure: collection of venous blood or arterial blood
At 2h after the last administration of ticagrelor 90mg in patients scheduled for coronary angiography (CAG), about 40mL blood samples were collected before operation and divided into 2mL round bottom frozen tubes, 1mL/tube to prepare blood clots. At 2h after the last administration of ticagrelor 90mg in patients scheduled for CAG, about 40mL blood samples were collected before operation and put into the citrate anticoagulant tube for platelet-poor plasma(PPP) extraction. 9mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for platelet aggregation function test. 40mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for PPP extraction.

Outcome Measures

Primary Outcome Measures

  1. the thrombolysis rate [1 hour]

Secondary Outcome Measures

  1. adenosine diphosphate-induced platelet aggregation rate. [3 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age 18-75 years old, body weight ≥45kg, regardless of gender;

  • aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours;

  • patients with suspected coronary atherosclerotic heart disease scheduled for coronary angiography or interventional therapy.

Exclusion Criteria:

  • Previous thrombolytic therapy with r-SAK;

  • A previous diagnosis of Staphylococcus aureus infection; ③ Those who are enrolled in other clinical trials; ④ And those who were deemed ineligible by other investigators.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chunjian Li, Director of Cardiology, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05978791
Other Study ID Numbers:
  • 021
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis

Study Results

No Results Posted as of Aug 9, 2023