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

NCT07712445 | Recruiting DMC

• 1 other identifier: 034
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Tenecteplase (TNK) is the latest generation of specific thrombolytic drugs independently developed in China. This study aims to investigate the thrombolytic efficacy of platelet membrane-coated tenecteplase (PM-TNK) on human ex vivo arterial thrombi, and to explore the inhibitory effects of plasma from patients receiving antiplatelet therapy on its thrombolytic activity, thereby evaluating the future clinical application value of PM-TNK.

Conditions

Arterial Thrombosis

Outcome Measures

Primary Outcomes (1)

• Thrombolysis rate

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

  60 min

Interventions

collection of venous blood or arterial blood OTHER

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 40mL 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).

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

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

You may qualify if:

• For CAD patients:
• 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;
• For healthy volunteer:
• Age 18-75 years old, body weight ≥45kg, regardless of gender

You may not qualify if:

• For CAD patients 1. Previous thrombolytic therapy with TNK; 2. Those who are enrolled in other clinical trials; 3. Those who were deemed ineligible by other investigators.
• For healthy volunteer:
• \. 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Chunjian Li

CONTACT

86-13701465229; lijay@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 30, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-06

Locations

CN (1)