Thrombolytic treatment using platelet membrane coated recombinant staphylokinase for arterial clots

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

This study is testing a new treatment using a special drug to see if it can safely dissolve blood clots in arteries for people with heart problems.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05978791 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of recombinant staphylokinase (r-SAK), a genetically engineered thrombolytic agent, in treating arterial thrombosis. It aims to evaluate the thrombolytic effect of r-SAK on human arterial thrombus, particularly focusing on its ability to dissolve platelet-rich clots without significantly increasing bleeding risks. The study will involve collecting venous or arterial blood from patients with suspected coronary artery disease and healthy volunteers to assess the revascularization rates compared to existing thrombolytic agents. The research is based on previous findings that suggest r-SAK has superior thrombolytic properties compared to traditional treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with suspected coronary artery disease who are scheduled for coronary angiography or interventional therapy.

Not a fit: Patients who have previously undergone thrombolytic therapy with r-SAK or have certain blood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients suffering from arterial thrombosis.

How similar studies have performed: Previous studies have shown promising results for r-SAK in animal models, indicating potential success for this approach in humans.

Eligibility criteria

For CAD patients:

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous thrombolytic therapy with r-SAK;
2. A previous diagnosis of Staphylococcus aureus infection;
3. Those who are enrolled in other clinical trials;
4. Those who were deemed ineligible by other investigators.

For healthy volunteer:

Inclusion Criteria:

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

Exclusion Criteria:

1. Currently taking any medication that may affect platelet function, such as antiplatelet drugs or nonsteroidal anti-inflammatory drugs.
2. 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.
3. 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).
4. Recent (within one month) severe trauma, surgery, or head injury.
5. Pregnant or lactating women.
6. Diabetes.
7. Smokers.
8. Those who are enrolled in other clinical trials;
9. Those who were deemed ineligible by other investigators.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chunjian Li, PhD

Conditions Arterial Thrombosis