Arterial ThrombosisNCT05978791
Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase 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
Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). 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
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 1. patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy； 2. healthy volunteers.
Who may be able to join
- 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;
- 1. Age 18-75 years old, body weight ≥45kg, regardless of gender;
Who cannot join
- Previous thrombolytic therapy with r-SAK;
- A previous diagnosis of Staphylococcus aureus infection;
- Those who are enrolled in other clinical trials;
- 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.
Show all 14Show fewer
- 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.
- 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).
- Recent (within one month) severe trauma, surgery, or head injury.
- Pregnant or lactating women.
- Diabetes.
- Smokers.
- Those who are enrolled in other clinical trials;
- Those who were deemed ineligible by other investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Chunjian Li, PHD, +86 13701465229, lijay@njmu.edu.cn
Rui Hua, MBBS, +86 13196825735, huarui0914@126.com
About this study
Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK, is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve clots in a short period of time without significantly increasing the risk of bleeding, especially for platelet-rich arterial clots. Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy. Inspired by the natural affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.
Read the detailed description
Currently, the most important treatment for thrombus and related cardiovascular diseases is prevention, but in the case of long-term thrombosis, the main treatment options include balloon catheters, surgical removal of embolus, thrombolytic therapy, and other related operations. Considering the cost of surgical treatment and its damage to the body, thrombolytic therapy has become one of the most effective ways to achieve rapid thrombus clearance and recanalization of blocked blood vessels in thrombotic diseases.
Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK, is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve clots in a short period of time without significantly increasing the risk of bleeding, especially for platelet-rich arterial clots. Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy. Inspired by the natural affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.
- 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 bloodProcedure or surgery
- 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).
- 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).
- Healthy volunteer (group 1) collected 40 mL blood samples into sodium citrate anticoagulant tubes (for preparation of PPP).
- Healthy volunteer (group 2) collected 9 mL venous blood samples (for platelet aggregation assay).
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients with suspected coronary artery disease | Take aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours Receives: Procedure: collection of venous blood or arterial blood | |
| healthy volunteers | Age 18-75 years old, body weight ≥45kg, regardless of gender; Receives: Procedure: collection of venous blood or arterial blood |
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
Secondary outcomes (1)
Adenosine diphosphate-induced platelet aggregation rate.
9 mL venous blood was collected from healthy volunteers (group 2) into 3.2% sodium citrate tubes and subjected to platelet aggregation assay by light transmission aggregometry within 120min.Also test the effect of 20% aspirin- and ticagrelor-treated PPP and 20% healthy volunteers (group 1) PPP on platelet aggregation.
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start11 Oct 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- 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
- NCT05978791
- Sponsor's protocol ID
- 021
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
PubMed 29367334Tillett WS, Garner RL. THE FIBRINOLYTIC ACTIVITY OF HEMOLYTIC STREPTOCOCCI. J Exp Med. 1933 Sep 30;58(4):485-502. doi: 10.1084/jem.58.4.485.
PubMed 19870210MACFARLANE RG, PILLING J. Fibrinolytic activity of normal urine. Nature. 1947 Jun 7;159(4049):779. doi: 10.1038/159779a0. No abstract available.
PubMed 20241608Rijken DC, Collen D. Purification and characterization of the plasminogen activator secreted by human melanoma cells in culture. J Biol Chem. 1981 Jul 10;256(13):7035-41.
PubMed 6787058Noble S, McTavish D. Reteplase. A review of its pharmacological properties and clinical efficacy in the management of acute myocardial infarction. Drugs. 1996 Oct;52(4):589-605. doi: 10.2165/00003495-199652040-00012.
PubMed 8891469Simpson D, Siddiqui MA, Scott LJ, Hilleman DE. Reteplase: a review of its use in the management of thrombotic occlusive disorders. Am J Cardiovasc Drugs. 2006;6(4):265-85. doi: 10.2165/00129784-200606040-00007.
PubMed 16913828Nordt TK, Bode C. Thrombolysis: newer thrombolytic agents and their role in clinical medicine. Heart. 2003 Nov;89(11):1358-62. doi: 10.1136/heart.89.11.1358. No abstract available.
PubMed 14594904Ross AM, Gao R, Coyne KS, Chen J, Yao K, Yang Y, Qin X, Qiao S, Yao M; TUCC Investigators. A randomized trial confirming the efficacy of reduced dose recombinant tissue plasminogen activator in a Chinese myocardial infarction population and demonstrating superiority to usual dose urokinase: the TUCC trial. Am Heart J. 2001 Aug;142(2):244-7. doi: 10.1067/mhj.2001.116963.
PubMed 11479462Gao RL, Han YL, Yang XC, Mao JM, Fang WY, Wang L, Shen WF, Li ZQ, Jia GL, Lu SZ, Wei M, Zeng DY, Chen JL, Qin XW, Xu B, DU CH; Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction (RESTART). Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial. Chin Med J (Engl). 2010 Jun;123(11):1365-72.
PubMed 20819587Nedaeinia R, Faraji H, Javanmard SH, Ferns GA, Ghayour-Mobarhan M, Goli M, Mashkani B, Nedaeinia M, Haghighi MHH, Ranjbar M. Bacterial staphylokinase as a promising third-generation drug in the treatment for vascular occlusion. Mol Biol Rep. 2020 Jan;47(1):819-841. doi: 10.1007/s11033-019-05167-x. Epub 2019 Nov 1.
PubMed 31677034Toombs CF. New directions in thrombolytic therapy. Curr Opin Pharmacol. 2001 Apr;1(2):164-8. doi: 10.1016/s1471-4892(01)00030-3.
PubMed 11714091Szemraj J, Stankiewicz A, Rozmyslowicz-Szerminska W, Mogielnicki A, Gromotowicz A, Buczko W, Oszajca K, Bartkowiak J, Chabielska E. A new recombinant thrombolytic and antithrombotic agent with higher fibrin affinity - a staphylokinase variant. An in-vivo study. Thromb Haemost. 2007 Jun;97(6):1037-45. doi: 10.1160/th06-10-0562.
PubMed 17549308Li CJ, Huang J, Yang ZJ, Cao KJ. Thrombolytic efficacy of native recombinant staphylokinase on femoral artery thrombus of rabbits. Acta Pharmacol Sin. 2007 Jan;28(1):58-65. doi: 10.1111/j.1745-7254.2007.00455.x.
PubMed 17184583Vanderschueren S, Barrios L, Kerdsinchai P, Van den Heuvel P, Hermans L, Vrolix M, De Man F, Benit E, Muyldermans L, Collen D, et al. A randomized trial of recombinant staphylokinase versus alteplase for coronary artery patency in acute myocardial infarction. The STAR Trial Group. Circulation. 1995 Oct 15;92(8):2044-9. doi: 10.1161/01.cir.92.8.2044.
PubMed 7554180Kamaly N, Yameen B, Wu J, Farokhzad OC. Degradable Controlled-Release Polymers and Polymeric Nanoparticles: Mechanisms of Controlling Drug Release. Chem Rev. 2016 Feb 24;116(4):2602-63. doi: 10.1021/acs.chemrev.5b00346. Epub 2016 Feb 8.
PubMed 26854975
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human Arterial Thrombus
- ClinicalTrials.gov ID
- NCT05978791
- Acronym / sponsor ID
- 021
- Conditions
- Arterial Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Aug 2023 (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.
Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK, is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve clots in a short period of time without significantly increasing the risk of bleeding, especially for platelet-rich arterial clots. Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy. Inspired by the natural affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.
Detailed description
Currently, the most important treatment for thrombus and related cardiovascular diseases is prevention, but in the case of long-term thrombosis, the main treatment options include balloon catheters, surgical removal of embolus, thrombolytic therapy, and other related operations. Considering the cost of surgical treatment and its damage to the body, thrombolytic therapy has become one of the most effective ways to achieve rapid thrombus clearance and recanalization of blocked blood vessels in thrombotic diseases.
Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK, is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve clots in a short period of time without significantly increasing the risk of bleeding, especially for platelet-rich arterial clots. Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy. Inspired by the natural affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients with suspected coronary artery disease | – | Procedure: collection of venous blood or arterial bloodTake aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours |
| healthy volunteers | – | Procedure: collection of venous blood or arterial bloodAge 18-75 years old, body weight ≥45kg, regardless of gender; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy； 2. healthy volunteers.
Key inclusion criteria (4 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;
- 1. Age 18-75 years old, body weight ≥45kg, regardless of gender;
Key exclusion criteria (14 listed)
- Previous thrombolytic therapy with r-SAK;
- A previous diagnosis of Staphylococcus aureus infection;
- Those who are enrolled in other clinical trials;
- Those who were deemed ineligible by other investigators.
- Currently taking any medication that may affect platelet function, such as antiplatelet drugs or nonsteroidal anti-inflammatory drugs.
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 40 mL 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). | Procedure or surgery | Hospitalized patients with suspected coronary artery disease, healthy volunteers |
Primary outcome
Thrombolysis rate
Time frame: 60 min
Thrombolysis rate (%) = [(initial clot weight - final clot weight) / initial clot weight] × 100%.
1 secondary outcome
Adenosine diphosphate-induced platelet aggregation rate.
Time frame: 120 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 29367334Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
- Background: PubMed 19870210Tillett WS, Garner RL. THE FIBRINOLYTIC ACTIVITY OF HEMOLYTIC STREPTOCOCCI. J Exp Med. 1933 Sep 30;58(4):485-502. doi: 10.1084/jem.58.4.485.
- Background: PubMed 20241608MACFARLANE RG, PILLING J. Fibrinolytic activity of normal urine. Nature. 1947 Jun 7;159(4049):779. doi: 10.1038/159779a0. No abstract available.
- Background: PubMed 6787058Rijken DC, Collen D. Purification and characterization of the plasminogen activator secreted by human melanoma cells in culture. J Biol Chem. 1981 Jul 10;256(13):7035-41.
- Background: PubMed 8891469Noble S, McTavish D. Reteplase. A review of its pharmacological properties and clinical efficacy in the management of acute myocardial infarction. Drugs. 1996 Oct;52(4):589-605. doi: 10.2165/00003495-199652040-00012.
- Background: PubMed 16913828Simpson D, Siddiqui MA, Scott LJ, Hilleman DE. Reteplase: a review of its use in the management of thrombotic occlusive disorders. Am J Cardiovasc Drugs. 2006;6(4):265-85. doi: 10.2165/00129784-200606040-00007.
- Background: PubMed 14594904Nordt TK, Bode C. Thrombolysis: newer thrombolytic agents and their role in clinical medicine. Heart. 2003 Nov;89(11):1358-62. doi: 10.1136/heart.89.11.1358. No abstract available.
- Background: PubMed 11479462Ross AM, Gao R, Coyne KS, Chen J, Yao K, Yang Y, Qin X, Qiao S, Yao M; TUCC Investigators. A randomized trial confirming the efficacy of reduced dose recombinant tissue plasminogen activator in a Chinese myocardial infarction population and demonstrating superiority to usual dose urokinase: the TUCC trial. Am Heart J. 2001 Aug;142(2):244-7. doi: 10.1067/mhj.2001.116963.
- Background: PubMed 20819587Gao RL, Han YL, Yang XC, Mao JM, Fang WY, Wang L, Shen WF, Li ZQ, Jia GL, Lu SZ, Wei M, Zeng DY, Chen JL, Qin XW, Xu B, DU CH; Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction (RESTART). Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial. Chin Med J (Engl). 2010 Jun;123(11):1365-72.
- Background: PubMed 31677034Nedaeinia R, Faraji H, Javanmard SH, Ferns GA, Ghayour-Mobarhan M, Goli M, Mashkani B, Nedaeinia M, Haghighi MHH, Ranjbar M. Bacterial staphylokinase as a promising third-generation drug in the treatment for vascular occlusion. Mol Biol Rep. 2020 Jan;47(1):819-841. doi: 10.1007/s11033-019-05167-x. Epub 2019 Nov 1.
- Background: PubMed 11714091Toombs CF. New directions in thrombolytic therapy. Curr Opin Pharmacol. 2001 Apr;1(2):164-8. doi: 10.1016/s1471-4892(01)00030-3.
- Background: PubMed 17549308Szemraj J, Stankiewicz A, Rozmyslowicz-Szerminska W, Mogielnicki A, Gromotowicz A, Buczko W, Oszajca K, Bartkowiak J, Chabielska E. A new recombinant thrombolytic and antithrombotic agent with higher fibrin affinity - a staphylokinase variant. An in-vivo study. Thromb Haemost. 2007 Jun;97(6):1037-45. doi: 10.1160/th06-10-0562.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunjian Li, PhD (+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?
On the ClinicalTrials.gov record for NCT05978791, which also lists 25 linked publications.
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 12 Oct 2023.