<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/NCT02211066</url>
  </required_header>
  <id_info>
    <org_study_id>TIGER-BVS</org_study_id>
    <secondary_id>2013-002675-17</secondary_id>
    <nct_id>NCT02211066</nct_id>
  </id_info>
  <brief_title>TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization</brief_title>
  <acronym>TIGER-BVS</acronym>
  <official_title>TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single-centre, randomized, active controlled, open label clinical trial. The&#xD;
      primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately&#xD;
      after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used&#xD;
      in both arms at the approved doses and for the approved duration therapy of 1-year. The&#xD;
      secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with&#xD;
      ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is&#xD;
      tested in the second randomization. The angiographic follow-up will be scheduled at 1 or&#xD;
      3-year follow-up in order to test the secondary hypothesis either at the moment of the end of&#xD;
      the antiplatelet therapy or at the moment of scaffold bioresorption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.</measure>
    <time_frame>1 and 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)</condition>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clopidogrel 75 mg will be administered daily for 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ticagrelor 90 mg will be administered daily for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Clopidogrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor</intervention_name>
    <arm_group_label>Ticagrelor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes, older than 18 years old.&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
          -  Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1,&#xD;
             2, 3 or 4) or patients with documented silent ischemia by stress test during the last&#xD;
             year.&#xD;
&#xD;
          -  Patients eligible for coronary revascularization in a coronary chronic total&#xD;
             occlusion, which was angiographically documented in a previous coronary angiography&#xD;
             during the last year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or women of childbearing potential who do not use adequate&#xD;
             contraception.&#xD;
&#xD;
          -  Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM)&#xD;
             heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.&#xD;
&#xD;
          -  Participation in other studies.&#xD;
&#xD;
          -  Life expectancy of less than one year or factors making clinical and/or angiographic&#xD;
             follow-up difficult.&#xD;
&#xD;
          -  Planned cardiac surgery or major non-cardiac surgery.&#xD;
&#xD;
          -  The subject has a history of bleeding diathesis or coagulopathy.&#xD;
&#xD;
          -  The subject suffered disabling stroke within the past year.&#xD;
&#xD;
          -  Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine&#xD;
             dysfunction, which, in the judgment of the Investigator, may affect the patient's&#xD;
             ability to complete the study.&#xD;
&#xD;
          -  History of malignancy, except in patients who have been disease-free &gt;5 years or whose&#xD;
             only malignancy has been basal or squamous cell skin carcinoma.&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salvatore Brugaletta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Juan A. Arnaiz</investigator_full_name>
    <investigator_title>Clinical Trial Manager</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02211066
org study id: TIGER-BVS
secondary id: 2013-002675-17
nct id: NCT02211066
lead sponsor: 
collaborator: 
has dmc: No
The study is a single-centre, randomized, active controlled, open label clinical trial. The
      primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately
      after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)
The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used
      in both arms at the approved doses and for the approved duration therapy of 1-year. The
      secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with
      ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is
      tested in the second randomization. The angiographic follow-up will be scheduled at 1 or
      3-year follow-up in order to test the secondary hypothesis either at the moment of the end of
      the antiplatelet therapy or at the moment of scaffold bioresorption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.
time frame: Baseline
measure: Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.
time frame: Baseline
measure: Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.
time frame: Baseline
measure: Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 1 year
measure: Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group
time frame: 1 year
measure: Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 1 year
measure: Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 3 years
measure: Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 3 years
measure: Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 3 years
measure: Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group.
time frame: 1 year
measure: Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group.
time frame: 3 years
measure: Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.
time frame: 1 and 3 years
arm group label: Clopidogrel
arm group type: Active Comparator
description: Clopidogrel 75 mg will be administered daily for 1 year
arm group label: Ticagrelor
arm group type: Experimental
description: Ticagrelor 90 mg will be administered daily for 1 year
intervention type: Drug
intervention name: Clopidogrel
arm group label: Clopidogrel
intervention type: Drug
intervention name: Ticagrelor
arm group label: Ticagrelor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salvatore Brugaletta, MD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Juan A. Arnaiz
investigator title: Clinical Trial Manager
mesh term: Clopidogrel
mesh term: Ticagrelor