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RecruitingNCT07712445Updated Jul 17, 2026

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

An observational study in Arterial Thrombosis, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Arterial Thrombosis
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

-

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

Exclusion criteria

Exclusion Criteria:

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:

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.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Interventions

  • Othercollection 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 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).

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What researchers measure

Primary outcomes

  1. Thrombolysis rate

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

    Time frame: 60 min

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    • The First Affiliated Hospital with Nanjing Medical University · Contact · jsphkj@163.com · 86-025-68306360
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07712445
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Chunjian Li (Chief physician, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jul 17, 2026
Start date
Jun 30, 2026
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Chunjian Li
Contact
lijay@njmu.edu.cn
86-13701465229

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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