Arterial ThrombosisNCT07712445
Study on the Thrombolytic Effect of Platelet Membrane Coated Tenecteplase on Human Arterial Thrombus
An observational study of Arterial Thrombosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Thrombosis
- What is being tested?
- collection of venous blood or arterial blood
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy； healthy volunteers.
Who may be able to join
- -
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
The First Affiliated Hospital with Nanjing Medical University, 86-025-68306360, jsphkj@163.com
About this study
Official title: Platelet Membrane-coated Tenecteplase to Improve Thrombolytic Efficacy by Targeting Thrombus
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
- Being tested
- collection of venous blood or arterial blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of venous blood or arterial bloodOther
- 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolysis rate
Thrombolysis rate (%) = [(initial clot weight - final clot weight) / initial clot weight] × 100%.
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start30 Jun 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial ThrombosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712445
- Sponsor's protocol ID
- 034
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Membrane-coated Tenecteplase to Improve Thrombolytic Efficacy by Targeting Thrombus
- ClinicalTrials.gov ID
- NCT07712445
- Acronym / sponsor ID
- 034
- Conditions
- Arterial Thrombosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy； healthy volunteers.
Key inclusion criteria (6 listed)
- -
- 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;
- Age 18-75 years old, body weight ≥45kg, regardless of gender
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of venous blood or arterial blood1. 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). | Other | – |
Primary outcome
Thrombolysis rate
Time frame: 60 min
Thrombolysis rate (%) = [(initial clot weight - final clot weight) / initial clot weight] × 100%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Thrombosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunjian Li (86-13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolysis rate (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.