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

NCT05978791 | Unknown

• 1 other identifier: 021
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Thrombosis

Outcome Measures

Primary Outcomes (1)

• Thrombolysis rate

  Thrombolysis rate (%) = \[(initial clot weight - final clot weight) / initial clot weight\] × 100%.

  60 min

Secondary Outcomes (1)

• Adenosine diphosphate-induced platelet aggregation rate.

  120 min

Study Arms (2)

Hospitalized patients with suspected coronary artery disease

Take 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

healthy volunteers

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

Procedure: collection of venous blood or arterial blood

Interventions

collection of venous blood or arterial blood PROCEDURE

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).

Hospitalized patients with suspected coronary artery disease; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy； 2. healthy volunteers.

You may qualify if:

• Age 18-75 years old, body weight ≥45kg, regardless of gender;
• Patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy.
• Take aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours;

You may not qualify if:

• Previous thrombolytic therapy with r-SAK;
• A previous diagnosis of Staphylococcus aureus infection;
• Those who are enrolled in other clinical trials;
• Those who were deemed ineligible by other investigators.
• For healthy volunteer:
• \. Age 18-75 years old, body weight ≥45kg, regardless of gender;
• Currently taking any medication that may affect platelet function, such as antiplatelet drugs or nonsteroidal anti-inflammatory drugs.
• Individuals with blood disorders, active bleeding or a tendency to bleed, including platelet count \<100×10\^9/L, hemoglobin \<100g/L, or recent bleeding in the digestive system or urinary tract within one month.
• Individuals with impaired liver or kidney function, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels above the upper limit of normal reference range, and estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73m\^2 (calculated based on the CKD-EPI equation).
• Recent (within one month) severe trauma, surgery, or head injury.
• Pregnant or lactating women.
• Diabetes.
• Smokers.
• Those who are enrolled in other clinical trials;
• Those who were deemed ineligible by other investigators.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

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Central Study Contacts

Chunjian Li, PhD

CONTACT

+86 13701465229; lijay@njmu.edu.cn

Rui Hua, MBBS

CONTACT

+86 13196825735; huarui0914@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: October 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)