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/NCT06015477</url>
    </required_header>
    <id_info>
      <org_study_id>SAC-TIDE</org_study_id>
      <nct_id>NCT06015477</nct_id>
    </id_info>
    <brief_title>Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracranial Aneurysm</brief_title>
    <acronym>SAC-TIDE</acronym>
    <official_title>Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Endovascular Treatment of Unruptured Intracranial Aneurysm (SAC-TIDE) ---a Pilot Study</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary goal of the trial is to investigate whether the experimental arms (receiving the&#xD;
        P2Y12 inhibitor Ticagrelor) compared with the control arm (taking dual antiplatelet therapy)&#xD;
        could reduce bleeding complications in patients with intracranial aneurysms undergoing&#xD;
        Stent-Assisted Coiling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bleeding complications associated with the use of DAPT have been of great concern, with up to&#xD;
        one-third of PCI patients treated with DAPT previously reported to suffer from nuisance&#xD;
        bleeding. Once any of these bleeding complications occur, adherence to the DAPT regimen may&#xD;
        become difficult. Antiplatelet agents are necessary for patients undergoing stent-assisted&#xD;
        spring coil embolisation of intracranial aneurysms and are key to reducing thrombosis leading&#xD;
        to ischaemic stroke events in post-procedural patients.&#xD;
  &#xD;
        Currently neither long-term DAPT nor short-duration DAPT followed by aspirin monotherapy is&#xD;
        fully satisfactory. Patients with aneurysms without underlying intracranial atherosclerotic&#xD;
        disease have relatively lower ischaemic risk factors, and antiplatelet medication after&#xD;
        stenting remains to be improved. Ticagrelor monotherapy was associated with a lower risk of&#xD;
        major bleeding and no measurable increase in ischaemic events after a short course of 1- or&#xD;
        3-month DAPT. The study indicated no difference in stroke or death between mono- and&#xD;
        dual-antiplatelet therapy after carotid artery placement, and P2Y12 inhibitor monotherapy may&#xD;
        be an effective strategy to reduce severe bleeding complications while preserving ischemic&#xD;
        benefits for patients. This study investigates the comparative efficacy and safety of&#xD;
        stent-assisted coiling therapy for intracranial aneurysms after ticagrelor monotherapy as an&#xD;
        alternative to dual antiplatelet therapy, to reduce the incidence of bleeding complications&#xD;
        in patients, and thus to improve the antiplatelet strategy after stent-assisted coiling&#xD;
        therapy for intracranial aneurysms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year. All patients received oral clopidogrel 75 mg + aspirin 100 mg for 3-5 days preoperatively.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hemorrhage</measure>
      <time_frame>Within one year after surgery</time_frame>
      <description>The incidence of bleeding defined by Bleeding Academic Research Consortium</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.</measure>
      <time_frame>Within one year after surgery</time_frame>
      <description>Co-Primary Efficacy Endpoint (non-inferiority hypothesis)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ischemic stroke</measure>
      <time_frame>This will be assessed during the first year of follow-up.</time_frame>
      <description>ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent thrombosis</measure>
      <time_frame>Within one year after surgery</time_frame>
      <description>Stent thrombosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BARC 1-5 type bleeding</measure>
      <time_frame>Within one year after surgery</time_frame>
      <description>bleeding defined by Bleeding Academic Research Consortium</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Intracranial Aneurysm</condition>
    <condition>Stent Complication</condition>
    <arm_group>
      <arm_group_label>ticagrelor monotherapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ticagrelor monotherapy (starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.). After 1 month, continuation to ticagrelor monotherapy for 1 year.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual Antiplatelet Therapy group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ticagrelor monotherapy</intervention_name>
      <description>starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.</description>
      <arm_group_label>ticagrelor monotherapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dual Antiplatelet Therapy</intervention_name>
      <description>Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.</description>
      <arm_group_label>Dual Antiplatelet Therapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with a definitive diagnosis of an unruptured intracranial aneurysm with&#xD;
               imaging suggestive of an aneurysm &lt;10 mm&#xD;
  &#xD;
            2. Patients who successfully underwent stent-assisted spring coil treatment for&#xD;
               intracranial aneurysms without acute ischaemic or bleeding stroke events in the&#xD;
               perioperative period&#xD;
  &#xD;
            3. Age 18-45 years old&#xD;
  &#xD;
            4. Patients with no previous history of chronic diseases such as hypertension, diabetes&#xD;
               mellitus, coronary heart disease, hyperlipidaemia and so on&#xD;
  &#xD;
            5. Agreed to participate in this study and gave informed consent for the collection and&#xD;
               preservation of case data and the follow-up process.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Planned surgery or intervention during the experiment requiring study drug&#xD;
               discontinuation; (2) Contraindications requiring oral anticoagulation or aspirin or&#xD;
               clopidogrel; (3) History of severe central nervous system damage (e.g., as a result of&#xD;
               tumour, aneurysm, intracranial or spinal cord surgery); (4) Severe liver disease,&#xD;
               including hepatic failure, cirrhosis, portal hypertension (oesophageal varices),&#xD;
               active hepatitis; (5 ) severe renal dysfunction (creatinine more than 1.5 times the&#xD;
               upper limit of the normal range); (6) severe heart failure (NYHA class:III ~ IV); high&#xD;
               risk for chronic arrhythmias (1st or 2nd degree atrioventricular block due to sinus&#xD;
               node disease, bradycardic syncope without pacemaker); diagnosis or suspected diagnosis&#xD;
               of acute coronary syndrome; bacterial endocarditis, pericarditis; (7) severe&#xD;
               comorbidities or patients with active cancer with a life expectancy of less than 2&#xD;
               years; (8) participation in another clinical study using an experimental product&#xD;
               within the past 30 days; currently receiving an experimental drug or device; and (9)&#xD;
               pregnant, currently pregnant, or of childbearing potential without birth control or&#xD;
               breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hua Lu, Doctor</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hua Lu, Doctor</last_name>
      <phone>18761671021</phone>
      <email>luhua@njmu.edu.cn</email>
    </overall_contact>
    <results_reference>
      <citation>Ben-Dor I, Torguson R, Scheinowitz M, Li Y, Delhaye C, Wakabayashi K, Maluenda G, Syed AI, Collins SD, Gonzalez MA, Gaglia MA Jr, Xue Z, Kaneshige K, Satler LF, Suddath WO, Kent KM, Pichard AD, Waksman R. Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents. Am Heart J. 2010 May;159(5):871-5. doi: 10.1016/j.ahj.2010.01.016.</citation>
      <PMID>20435198</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim KS, Fraser JF, Grupke S, Cook AM. Management of antiplatelet therapy in patients undergoing neuroendovascular procedures. J Neurosurg. 2018 Oct;129(4):890-905. doi: 10.3171/2017.5.JNS162307. Epub 2017 Dec 1.</citation>
      <PMID>29192856</PMID>
    </results_reference>
    <results_reference>
      <citation>Nordeen JD, Patel AV, Darracott RM, Johns GS, Taussky P, Tawk RG, Miller DA, Freeman WD, Hanel RA. Clopidogrel Resistance by P2Y12 Platelet Function Testing in Patients Undergoing Neuroendovascular Procedures: Incidence of Ischemic and Hemorrhagic Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34.</citation>
      <PMID>23826440</PMID>
    </results_reference>
    <results_reference>
      <citation>Gutierrez J, Turan TN, Hoh BL, Chimowitz MI. Intracranial atherosclerotic stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2022 Apr;21(4):355-368. doi: 10.1016/S1474-4422(21)00376-8. Epub 2022 Feb 7. Erratum In: Lancet Neurol. 2022 Feb 16;:</citation>
      <PMID>35143758</PMID>
    </results_reference>
    <results_reference>
      <citation>Valgimigli M, Mehran R, Franzone A, da Costa BR, Baber U, Piccolo R, McFadden EP, Vranckx P, Angiolillo DJ, Leonardi S, Cao D, Dangas GD, Mehta SR, Serruys PW, Gibson CM, Steg GP, Sharma SK, Hamm C, Shlofmitz R, Liebetrau C, Briguori C, Janssens L, Huber K, Ferrario M, Kunadian V, Cohen DJ, Zurakowski A, Oldroyd KG, Yaling H, Dudek D, Sartori S, Kirkham B, Escaned J, Heg D, Windecker S, Pocock S, Juni P; SIDNEY Collaboration. Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis. JACC Cardiovasc Interv. 2021 Feb 22;14(4):444-456. doi: 10.1016/j.jcin.2020.11.046.</citation>
      <PMID>33602441</PMID>
    </results_reference>
    <results_reference>
      <citation>Jin Y, Huang H, Shu X, Chen S, Lu L, Gao X, Wu Z. P2Y12 inhibitor monotherapy and dual antiplatelet therapy after percutaneous coronary intervention: An updated meta-analysis of randomized trials. Thromb Res. 2021 Feb;198:115-121. doi: 10.1016/j.thromres.2020.11.038. Epub 2020 Dec 7.</citation>
      <PMID>33316640</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intracranial Aneurysm</keyword>
    <keyword>Stent-Assisted Coiling</keyword>
    <keyword>Ticagrelor</keyword>
    <keyword>Dual Antiplatelet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intracranial Aneurysm</mesh_term>
      <mesh_term>Aneurysm</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ticagrelor</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>the data will be available when summary data are published.</ipd_time_frame>
    </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/NCT06015477
  org study id: SAC-TIDE
  nct id: NCT06015477
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The primary goal of the trial is to investigate whether the experimental arms (receiving the
        P2Y12 inhibitor Ticagrelor) compared with the control arm (taking dual antiplatelet therapy)
        could reduce bleeding complications in patients with intracranial aneurysms undergoing
        Stent-Assisted Coiling.
  Bleeding complications associated with the use of DAPT have been of great concern, with up to
        one-third of PCI patients treated with DAPT previously reported to suffer from nuisance
        bleeding. Once any of these bleeding complications occur, adherence to the DAPT regimen may
        become difficult. Antiplatelet agents are necessary for patients undergoing stent-assisted
        spring coil embolisation of intracranial aneurysms and are key to reducing thrombosis leading
        to ischaemic stroke events in post-procedural patients.
  
        Currently neither long-term DAPT nor short-duration DAPT followed by aspirin monotherapy is
        fully satisfactory. Patients with aneurysms without underlying intracranial atherosclerotic
        disease have relatively lower ischaemic risk factors, and antiplatelet medication after
        stenting remains to be improved. Ticagrelor monotherapy was associated with a lower risk of
        major bleeding and no measurable increase in ischaemic events after a short course of 1- or
        3-month DAPT. The study indicated no difference in stroke or death between mono- and
        dual-antiplatelet therapy after carotid artery placement, and P2Y12 inhibitor monotherapy may
        be an effective strategy to reduce severe bleeding complications while preserving ischemic
        benefits for patients. This study investigates the comparative efficacy and safety of
        stent-assisted coiling therapy for intracranial aneurysms after ticagrelor monotherapy as an
        alternative to dual antiplatelet therapy, to reduce the incidence of bleeding complications
        in patients, and thus to improve the antiplatelet strategy after stent-assisted coiling
        therapy for intracranial aneurysms.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year. All patients received oral clopidogrel 75 mg + aspirin 100 mg for 3-5 days preoperatively.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Hemorrhage
  time frame: Within one year after surgery
  description: The incidence of bleeding defined by Bleeding Academic Research Consortium
  measure: Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.
  time frame: Within one year after surgery
  description: Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
  measure: ischemic stroke
  time frame: This will be assessed during the first year of follow-up.
  description: ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.
  measure: Stent thrombosis
  time frame: Within one year after surgery
  description: Stent thrombosis
  measure: BARC 1-5 type bleeding
  time frame: Within one year after surgery
  description: bleeding defined by Bleeding Academic Research Consortium
  arm group label: ticagrelor monotherapy group
  arm group type: Experimental
  description: Ticagrelor monotherapy (starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.). After 1 month, continuation to ticagrelor monotherapy for 1 year.
  arm group label: Dual Antiplatelet Therapy group
  arm group type: Active Comparator
  description: Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.
  intervention type: Drug
  intervention name: Ticagrelor monotherapy
  description: starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.
  arm group label: ticagrelor monotherapy group
  intervention type: Drug
  intervention name: Dual Antiplatelet Therapy
  description: Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.
  arm group label: Dual Antiplatelet Therapy group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hua Lu, Doctor
  role: Study Chair
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Hua Lu, Doctor
  phone: 18761671021
  email: luhua@njmu.edu.cn
  citation: Ben-Dor I, Torguson R, Scheinowitz M, Li Y, Delhaye C, Wakabayashi K, Maluenda G, Syed AI, Collins SD, Gonzalez MA, Gaglia MA Jr, Xue Z, Kaneshige K, Satler LF, Suddath WO, Kent KM, Pichard AD, Waksman R. Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents. Am Heart J. 2010 May;159(5):871-5. doi: 10.1016/j.ahj.2010.01.016.
  PMID: 20435198
  citation: Kim KS, Fraser JF, Grupke S, Cook AM. Management of antiplatelet therapy in patients undergoing neuroendovascular procedures. J Neurosurg. 2018 Oct;129(4):890-905. doi: 10.3171/2017.5.JNS162307. Epub 2017 Dec 1.
  PMID: 29192856
  citation: Nordeen JD, Patel AV, Darracott RM, Johns GS, Taussky P, Tawk RG, Miller DA, Freeman WD, Hanel RA. Clopidogrel Resistance by P2Y12 Platelet Function Testing in Patients Undergoing Neuroendovascular Procedures: Incidence of Ischemic and Hemorrhagic Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34.
  PMID: 23826440
  citation: Gutierrez J, Turan TN, Hoh BL, Chimowitz MI. Intracranial atherosclerotic stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2022 Apr;21(4):355-368. doi: 10.1016/S1474-4422(21)00376-8. Epub 2022 Feb 7. Erratum In: Lancet Neurol. 2022 Feb 16;:
  PMID: 35143758
  citation: Valgimigli M, Mehran R, Franzone A, da Costa BR, Baber U, Piccolo R, McFadden EP, Vranckx P, Angiolillo DJ, Leonardi S, Cao D, Dangas GD, Mehta SR, Serruys PW, Gibson CM, Steg GP, Sharma SK, Hamm C, Shlofmitz R, Liebetrau C, Briguori C, Janssens L, Huber K, Ferrario M, Kunadian V, Cohen DJ, Zurakowski A, Oldroyd KG, Yaling H, Dudek D, Sartori S, Kirkham B, Escaned J, Heg D, Windecker S, Pocock S, Juni P; SIDNEY Collaboration. Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis. JACC Cardiovasc Interv. 2021 Feb 22;14(4):444-456. doi: 10.1016/j.jcin.2020.11.046.
  PMID: 33602441
  citation: Jin Y, Huang H, Shu X, Chen S, Lu L, Gao X, Wu Z. P2Y12 inhibitor monotherapy and dual antiplatelet therapy after percutaneous coronary intervention: An updated meta-analysis of randomized trials. Thromb Res. 2021 Feb;198:115-121. doi: 10.1016/j.thromres.2020.11.038. Epub 2020 Dec 7.
  PMID: 33316640
  responsible party type: Sponsor
  mesh term: Intracranial Aneurysm
  mesh term: Aneurysm
  mesh term: Ticagrelor
  sharing ipd: Yes
  ipd description: Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: the data will be available when summary data are published.