Study on the Thrombolytic Effect of Platelet Membrane Coated Tenecteplase on Human Arterial Thrombus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of venous blood or arterial blood.
- Who it may be relevant to
- Registry conditions: Arterial Thrombosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Platelet Membrane-coated Tenecteplase to Improve Thrombolytic Efficacy by Targeting Thrombus
Overview
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.
Interventions
- Other collection 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 platele
Primary outcome measures
- Thrombolysis rate [Time frame: 60 min]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- The First Affiliated Hospital with Nanjing Medical University — Nanjing
Identifiers
NCT: NCT07712445 · 034