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/NCT06013020</url>
    </required_header>
    <id_info>
      <org_study_id>PREVENT</org_study_id>
      <nct_id>NCT06013020</nct_id>
    </id_info>
    <brief_title>Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus</brief_title>
    <official_title>Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zunyi Medical College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zunyi Medical College</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture,&#xD;
        triggers platelet activation/aggregation and thrombin generation, requires dual (platelet and&#xD;
        coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual&#xD;
        antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge,&#xD;
        since that increase in potential risk of bleeding.&#xD;
  &#xD;
        Although the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in&#xD;
        modern reperfusion therapy, including primary percutaneous coronary intervention (PCI),&#xD;
        remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an&#xD;
        OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited.&#xD;
        How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and&#xD;
        prevent LVT formation is challenging, since insufficient evidence is available from&#xD;
        randomized trials.&#xD;
  &#xD;
        Century Clot analyzer is point-of-care testing that could assess the coagulate state: normal,&#xD;
        hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether&#xD;
        Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the&#xD;
        hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT&#xD;
        formation without increasing major bleeding is uncertain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Prophylactic Rivaroxaban Therapy for Post STEMI Complicating Left VENtricular Thrombus&#xD;
        (PREVENT) study is designed to investigate the safety and efficacy of Century Clot-guided&#xD;
        additional low-dose rivaroxaban plus DAPT as an optimal antithrombotic strategy for&#xD;
        preventing LVT formation after anterior STEMI undergoing primary PCI.&#xD;
  &#xD;
        All eligible STEMI patients will be received standard DAPT (ticagrelor or clopidogrel plus&#xD;
        aspirin). At post-PCI 12-24 hours, to be randomly assigned into Century Clot (CR)-guided&#xD;
        rivaroxaban (2.5 mg twice daily for 1 month) in combination with DAPT and standard DAPT.&#xD;
        Omitting rivaroxaban at post-PCI 1 month, and both groups are following a tailored-ticagrelor&#xD;
        with dose reduction strategy (60 mg bid, or 45 mg bid if &lt;50 kg, ≥75 yrs) or clopidogrel (75&#xD;
        mg qd) plus aspirin (100 mg qd) for further 11 months. The clinical outcome is the incidence&#xD;
        of LVT formation, and net adverse clinical events (NACEs, composite of cardiac death,&#xD;
        non-fatal myocardial infarction, TVR/TLR, stroke, and major bleeding) at post-STEMI 1 month,&#xD;
        as well as at 12-month clinical follow-ups.&#xD;
  &#xD;
        In PREVENT study, the investigators hypothesize that Century Clot (CR)-guided additional&#xD;
        rivaroxaban prophylactic therapy could reduce LVT formation without increasing bleeding after&#xD;
        anterior STEMI, when compared with standard DAPT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">September 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of left ventricular thrombus (LVT) formation.</measure>
      <time_frame>At 1 month</time_frame>
      <description>Efficacy endpoint</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.</measure>
      <time_frame>At 1 month</time_frame>
      <description>Safety endpoint</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NACE (net adverse clinical event)</measure>
      <time_frame>At 12 months</time_frame>
      <description>The incidence of NACE, including cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, LVT formation, systemic embolism or stroke, and major bleeding.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">374</enrollment>
    <condition>STEMI - ST Elevation Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Guided NOAC and DAPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The first month: rivaroxaban 2.5 mg twice daily (if CR≥24) plus standard DAPT (ticagrelor 90 mg twice daily or clopidogrel 75 mg daily plus aspirin 100 mg daily).&#xD;
  The following 11 months: lower-dose ticagrelor 60 mg twice daily (45 mg twice daily if &lt;50 kg, ≥75 yrs) or clopidogrel (75 mg daily) plus aspirin (100 mg daily).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Unguided DAPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NOAC+DAPT</intervention_name>
      <description>Century Clot-guided rivaroxaban plus DAPT.</description>
      <arm_group_label>Guided NOAC and DAPT</arm_group_label>
      <other_name>Rivaroxaban + ticagrelor or clopidogrel + aspirin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DAPT</intervention_name>
      <description>Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.</description>
      <arm_group_label>Unguided DAPT</arm_group_label>
      <other_name>Ticagrelor or clopidogrel + aspirin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv)&#xD;
               ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.&#xD;
  &#xD;
            -  Patients provide written informed consent prior to enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intracranial, gastrointestinal, or urogenital bleeding within 6 months&#xD;
  &#xD;
            -  Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary&#xD;
               thromboembolism);&#xD;
  &#xD;
            -  Bleeding diathesis, thrombocytopenia (platelet &lt;100,000/mL) or hemoglobin &lt;10 g/dL,&#xD;
               and CRUSADE score-based high bleeding risk&#xD;
  &#xD;
            -  Hepatic dysfunction (serum liver enzyme&gt;3 times the normal limit)&#xD;
  &#xD;
            -  Renal failure (eGFR &lt;15 ml/min/1.73m2 or requiring dialysis)&#xD;
  &#xD;
            -  Severe chronic obstructive pulmonary disease&#xD;
  &#xD;
            -  Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without&#xD;
               pacemaker protection)&#xD;
  &#xD;
            -  Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor):&#xD;
               ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir,&#xD;
               saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin&#xD;
  &#xD;
            -  Life expectancy &lt; 1 year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cai De Jin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zunyi Medical College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cai De Jin, MD</last_name>
      <phone>86+178-0250-2582</phone>
      <email>jincaide@zmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yan Yan Jin, MD</last_name>
      <phone>86+157-7229-0925</phone>
      <email>jinyanyan850925@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Affiliated Hospital of Zunyi Medical University</name>
        <address>
          <city>Zunyi</city>
          <state>Guizhou</state>
          <zip>563003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cai De Jin, MD</last_name>
        <phone>86+178-0250-2582</phone>
        <email>jincaide@zmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Yan Yan Jin, MD</last_name>
        <phone>86+157-7229-0925</phone>
        <email>jinyanyan850925@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Cai De Jin, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Camaj A, Fuster V, Giustino G, Bienstock SW, Sternheim D, Mehran R, Dangas GD, Kini A, Sharma SK, Halperin J, Dweck MR, Goldman ME. Left Ventricular Thrombus Following Acute Myocardial Infarction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Mar 15;79(10):1010-1022. doi: 10.1016/j.jacc.2022.01.011.</citation>
      <PMID>35272796</PMID>
    </reference>
    <reference>
      <citation>Weitz JI, Angiolillo DJ, Geisler T, Heitmeier S. Dual Pathway Inhibition for Vascular Protection in Patients with Atherosclerotic Disease: Rationale and Review of the Evidence. Thromb Haemost. 2020 Aug;120(8):1147-1158. doi: 10.1055/s-0040-1713376. Epub 2020 Jun 28.</citation>
      <PMID>32594508</PMID>
    </reference>
    <reference>
      <citation>Yang WX, Lai CL, Chen FH, Wang JR, Ji YR, Wang DX. The value of Sonoclot detection technology to guide the clinical medication of the perioperative anticoagulation and antiplatelet therapy in patients with acute myocardial infarction undergoing emergent PCI. Exp Ther Med. 2017 Jun;13(6):2917-2921. doi: 10.3892/etm.2017.4336. Epub 2017 Apr 13.</citation>
      <PMID>28587360</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zunyi Medical College</investigator_affiliation>
      <investigator_full_name>Cai De Jin, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
      <mesh_term>Rivaroxaban</mesh_term>
      <mesh_term>Clopidogrel</mesh_term>
      <mesh_term>Ticagrelor</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06013020
  org study id: PREVENT
  nct id: NCT06013020
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture,
        triggers platelet activation/aggregation and thrombin generation, requires dual (platelet and
        coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual
        antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge,
        since that increase in potential risk of bleeding.
  
        Although the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in
        modern reperfusion therapy, including primary percutaneous coronary intervention (PCI),
        remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an
        OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited.
        How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and
        prevent LVT formation is challenging, since insufficient evidence is available from
        randomized trials.
  
        Century Clot analyzer is point-of-care testing that could assess the coagulate state: normal,
        hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether
        Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the
        hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT
        formation without increasing major bleeding is uncertain.
  The Prophylactic Rivaroxaban Therapy for Post STEMI Complicating Left VENtricular Thrombus
        (PREVENT) study is designed to investigate the safety and efficacy of Century Clot-guided
        additional low-dose rivaroxaban plus DAPT as an optimal antithrombotic strategy for
        preventing LVT formation after anterior STEMI undergoing primary PCI.
  
        All eligible STEMI patients will be received standard DAPT (ticagrelor or clopidogrel plus
        aspirin). At post-PCI 12-24 hours, to be randomly assigned into Century Clot (CR)-guided
        rivaroxaban (2.5 mg twice daily for 1 month) in combination with DAPT and standard DAPT.
        Omitting rivaroxaban at post-PCI 1 month, and both groups are following a tailored-ticagrelor
        with dose reduction strategy (60 mg bid, or 45 mg bid if <50 kg, ≥75 yrs) or clopidogrel (75
        mg qd) plus aspirin (100 mg qd) for further 11 months. The clinical outcome is the incidence
        of LVT formation, and net adverse clinical events (NACEs, composite of cardiac death,
        non-fatal myocardial infarction, TVR/TLR, stroke, and major bleeding) at post-STEMI 1 month,
        as well as at 12-month clinical follow-ups.
  
        In PREVENT study, the investigators hypothesize that Century Clot (CR)-guided additional
        rivaroxaban prophylactic therapy could reduce LVT formation without increasing bleeding after
        anterior STEMI, when compared with standard DAPT.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The incidence of left ventricular thrombus (LVT) formation.
  time frame: At 1 month
  description: Efficacy endpoint
  measure: The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.
  time frame: At 1 month
  description: Safety endpoint
  measure: NACE (net adverse clinical event)
  time frame: At 12 months
  description: The incidence of NACE, including cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, LVT formation, systemic embolism or stroke, and major bleeding.
  arm group label: Guided NOAC and DAPT
  arm group type: Experimental
  description: The first month: rivaroxaban 2.5 mg twice daily (if CR≥24) plus standard DAPT (ticagrelor 90 mg twice daily or clopidogrel 75 mg daily plus aspirin 100 mg daily).
  The following 11 months: lower-dose ticagrelor 60 mg twice daily (45 mg twice daily if <50 kg, ≥75 yrs) or clopidogrel (75 mg daily) plus aspirin (100 mg daily).
  arm group label: Unguided DAPT
  arm group type: Experimental
  description: The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.
  intervention type: Drug
  intervention name: NOAC+DAPT
  description: Century Clot-guided rivaroxaban plus DAPT.
  arm group label: Guided NOAC and DAPT
  other name: Rivaroxaban + ticagrelor or clopidogrel + aspirin
  intervention type: Drug
  intervention name: DAPT
  description: Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.
  arm group label: Unguided DAPT
  other name: Ticagrelor or clopidogrel + aspirin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Cai De Jin, MD
  role: Principal Investigator
  affiliation: Zunyi Medical College
  last name: Cai De Jin, MD
  phone: 86+178-0250-2582
  email: jincaide@zmu.edu.cn
  last name: Yan Yan Jin, MD
  phone: 86+157-7229-0925
  email: jinyanyan850925@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Camaj A, Fuster V, Giustino G, Bienstock SW, Sternheim D, Mehran R, Dangas GD, Kini A, Sharma SK, Halperin J, Dweck MR, Goldman ME. Left Ventricular Thrombus Following Acute Myocardial Infarction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Mar 15;79(10):1010-1022. doi: 10.1016/j.jacc.2022.01.011.
  PMID: 35272796
  citation: Weitz JI, Angiolillo DJ, Geisler T, Heitmeier S. Dual Pathway Inhibition for Vascular Protection in Patients with Atherosclerotic Disease: Rationale and Review of the Evidence. Thromb Haemost. 2020 Aug;120(8):1147-1158. doi: 10.1055/s-0040-1713376. Epub 2020 Jun 28.
  PMID: 32594508
  citation: Yang WX, Lai CL, Chen FH, Wang JR, Ji YR, Wang DX. The value of Sonoclot detection technology to guide the clinical medication of the perioperative anticoagulation and antiplatelet therapy in patients with acute myocardial infarction undergoing emergent PCI. Exp Ther Med. 2017 Jun;13(6):2917-2921. doi: 10.3892/etm.2017.4336. Epub 2017 Apr 13.
  PMID: 28587360
  responsible party type: Principal Investigator
  investigator affiliation: Zunyi Medical College
  investigator full name: Cai De Jin, MD
  investigator title: Principal Investigator
  mesh term: Myocardial Infarction
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Infarction
  mesh term: Aspirin
  mesh term: Rivaroxaban
  mesh term: Clopidogrel
  mesh term: Ticagrelor