xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05978791</url>
    </required_header>
    <id_info>
      <org_study_id>021</org_study_id>
      <nct_id>NCT05978791</nct_id>
    </id_info>
    <brief_title>Study on the Thrombolytic Effect of Platelet Membrane Cloaked Recombinant Staphylokinase on Human Arterial Thrombus</brief_title>
    <official_title>Study on the Thrombolytic Effect of Platelet Membrane Cloaked Recombinant Staphylokinase on Human Arterial Thrombus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by&#xD;
        genetic engineering technology in 1985, which has better thrombolytic effect than&#xD;
        streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK,&#xD;
        is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve&#xD;
        clots in a short period of time without significantly increasing the risk of bleeding,&#xD;
        especially for platelet-rich arterial clots. Previous studies have shown that the&#xD;
        thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK&#xD;
        at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The&#xD;
        revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly&#xD;
        higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may&#xD;
        provide a new solution for the existing thrombolytic therapy. Inspired by the natural&#xD;
        affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a&#xD;
        thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and&#xD;
        compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human&#xD;
        arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Currently, the most important treatment for thrombus and related cardiovascular diseases is&#xD;
        prevention, but in the case of long-term thrombosis, the main treatment options include&#xD;
        balloon catheters, surgical removal of embolus, thrombolytic therapy, and other related&#xD;
        operations. Considering the cost of surgical treatment and its damage to the body,&#xD;
        thrombolytic therapy has become one of the most effective ways to achieve rapid thrombus&#xD;
        clearance and recanalization of blocked blood vessels in thrombotic diseases.&#xD;
  &#xD;
        Recombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by&#xD;
        genetic engineering technology in 1985, which has better thrombolytic effect than&#xD;
        streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK,&#xD;
        is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve&#xD;
        clots in a short period of time without significantly increasing the risk of bleeding,&#xD;
        especially for platelet-rich arterial clots. Previous studies have shown that the&#xD;
        thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK&#xD;
        at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The&#xD;
        revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly&#xD;
        higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may&#xD;
        provide a new solution for the existing thrombolytic therapy. Inspired by the natural&#xD;
        affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a&#xD;
        thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK（PLT-SAK）and&#xD;
        compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human&#xD;
        arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the thrombolysis rate</measure>
      <time_frame>1 hour</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>adenosine diphosphate-induced platelet aggregation rate.</measure>
      <time_frame>3 hour</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Arterial Thrombosis</condition>
    <arm_group>
      <arm_group_label>Hospitalized patients with suspected coronary artery disease</arm_group_label>
      <description>aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy volunteers</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>collection of venous blood or arterial blood</intervention_name>
      <description>At 2h after the last administration of ticagrelor 90mg in patients scheduled for coronary angiography (CAG), about 40mL blood samples were collected before operation and divided into 2mL round bottom frozen tubes, 1mL/tube to prepare blood clots.&#xD;
  At 2h after the last administration of ticagrelor 90mg in patients scheduled for CAG, about 40mL blood samples were collected before operation and put into the citrate anticoagulant tube for platelet-poor plasma(PPP) extraction.&#xD;
  9mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for platelet aggregation function test.&#xD;
  40mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for PPP extraction.</description>
      <arm_group_label>Hospitalized patients with suspected coronary artery disease</arm_group_label>
      <arm_group_label>healthy volunteers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ① patients with suspected coronary atherosclerotic heart disease scheduled for coronary&#xD;
          angiography or interventional therapy；&#xD;
  &#xD;
          ② healthy volunteers.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-75 years old, body weight ≥45kg, regardless of gender;&#xD;
  &#xD;
                 -  aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin&#xD;
                    (300mg) and ticagrelor (180mg) ≥12 hours;&#xD;
  &#xD;
                      -  patients with suspected coronary atherosclerotic heart disease scheduled for&#xD;
                         coronary angiography or interventional therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous thrombolytic therapy with r-SAK;&#xD;
  &#xD;
                 -  A previous diagnosis of Staphylococcus aureus infection; ③ Those who are enrolled&#xD;
                    in other clinical trials; ④ And those who were deemed ineligible by other&#xD;
                    investigators.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chunjian Li, PhD</last_name>
      <phone>+86 13701465229</phone>
      <email>lijay@njmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rui Hua, MBBS</last_name>
      <phone>+86 13196825735</phone>
      <email>huarui0914@126.com</email>
    </overall_contact_backup>
    <reference>
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    </reference>
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      <citation>MACFARLANE RG, PILLING J. Fibrinolytic activity of normal urine. Nature. 1947 Jun 7;159(4049):779. doi: 10.1038/159779a0. No abstract available.</citation>
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      <PMID>29111341</PMID>
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      <citation>Ma YH, Liu CH, Liang Y, Chen JP, Wu T. Targeted Delivery of Plasminogen Activators for Thrombolytic Therapy: An Integrative Evaluation. Molecules. 2019 Sep 19;24(18):3407. doi: 10.3390/molecules24183407.</citation>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Chunjian Li</investigator_full_name>
      <investigator_title>Director of Cardiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05978791
  org study id: 021
  nct id: NCT05978791
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Case-Control
  time perspective: Prospective
  measure: the thrombolysis rate
  time frame: 1 hour
  measure: adenosine diphosphate-induced platelet aggregation rate.
  time frame: 3 hour
  arm group label: Hospitalized patients with suspected coronary artery disease
  description: aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours
  arm group label: healthy volunteers
  intervention type: Procedure
  intervention name: collection of venous blood or arterial blood
  description: At 2h after the last administration of ticagrelor 90mg in patients scheduled for coronary angiography (CAG), about 40mL blood samples were collected before operation and divided into 2mL round bottom frozen tubes, 1mL/tube to prepare blood clots.
  At 2h after the last administration of ticagrelor 90mg in patients scheduled for CAG, about 40mL blood samples were collected before operation and put into the citrate anticoagulant tube for platelet-poor plasma(PPP) extraction.
  9mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for platelet aggregation function test.
  40mL venous blood samples from healthy volunteers were collected and put into sodium citrate anticoagulant tubes for PPP extraction.
  arm group label: Hospitalized patients with suspected coronary artery disease
  arm group label: healthy volunteers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chunjian Li, PhD
  phone: +86 13701465229
  email: lijay@njmu.edu.cn
  last name: Rui Hua, MBBS
  phone: +86 13196825735
  email: huarui0914@126.com
  citation: 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. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:
  PMID: 29367334
  citation: Tillett 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.
  PMID: 19870210
  citation: MACFARLANE RG, PILLING J. Fibrinolytic activity of normal urine. Nature. 1947 Jun 7;159(4049):779. doi: 10.1038/159779a0. No abstract available.
  PMID: 20241608
  citation: Rijken 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.
  PMID: 6787058
  citation: Noble 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.
  PMID: 8891469
  citation: Simpson 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.
  PMID: 16913828
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  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
  investigator full name: Chunjian Li
  investigator title: Director of Cardiology
  mesh term: Thrombosis
  sharing ipd: No