<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/NCT01715714</url>
  </required_header>
  <id_info>
    <org_study_id>Uni-Koeln-1341</org_study_id>
    <secondary_id>2011-001795-19</secondary_id>
    <secondary_id>DRKS00000753</secondary_id>
    <nct_id>NCT01715714</nct_id>
  </id_info>
  <brief_title>Statin Recapture Therapy Before Coronary Artery Bypass Grafting</brief_title>
  <acronym>StaRT-CABG</acronym>
  <official_title>Statin Recapture Therapy Before Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at&#xD;
      risk for postoperative complications after surgery. The StaRT-CABG trial is the first&#xD;
      large-scale (2,630 patients) that will investigate whether an additional treatment with&#xD;
      statins (lipid-lowering medication) in high doses before CABG surgery can reduce the&#xD;
      incidence of major post-surgery complications including death, myocardial infarction and&#xD;
      stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in&#xD;
      Germany and is expected to provide relevant clinical data on the efficacy of this novel&#xD;
      treatment in order to optimize the care for all patients undergoing CABG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG)&#xD;
      are still at significant risk for postoperative major adverse cardiocerebral events (≈15%&#xD;
      MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence&#xD;
      shows that cardioprotection in patients receiving chronic statin treatment can be further&#xD;
      improved by a high-dose statin 'recapture' therapy given shortly before an&#xD;
      ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in&#xD;
      patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems&#xD;
      particularly promising, as myocardial injury, surgery-related inflammation and pre-existing&#xD;
      patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be&#xD;
      improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale&#xD;
      (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind&#xD;
      and placebo-controlled trial that aims to test whether an acute high-dose statin recapture&#xD;
      therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery&#xD;
      (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and&#xD;
      cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical&#xD;
      data on the efficacy of this novel therapeutic approach in order to optimize the care for all&#xD;
      CAD patients undergoing CABG with broad clinical implications on current clinical practice&#xD;
      and existing guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2012</start_date>
  <completion_date type="Actual">September 27, 2020</completion_date>
  <primary_completion_date type="Actual">April 24, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiocerebral events (MACCE) within 30 days after CABG.</measure>
    <time_frame>30 days after Surgery</time_frame>
    <description>Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events</measure>
    <time_frame>30 days after Surgery</time_frame>
    <description>Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>within the first 15 days after surgery (plus or minus 5 days)</time_frame>
    <description>Length of stay on intensive care unit (ICU) and hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat coronary revascularisation</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Repeat coronary revascularisation (PCI or CABG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at 12 months</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>All-cause mortality at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Infections</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Surgical site wound infections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>within the first 15 days after surgery (plus or minus 5 days)</time_frame>
    <description>New-onset postoperative atrial fibrillation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2630</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Statin Recapture Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin* on admission. (*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo given orally 12 hrs and 2 hrs before CABG</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Statin Recapture Therapy</intervention_name>
    <description>Given 12h and 2h before CABG</description>
    <arm_group_label>Statin Recapture Therapy</arm_group_label>
    <other_name>Simvastatin 80 mg</other_name>
    <other_name>Atorvastatin 80 mg</other_name>
    <other_name>Pravastatin 40 mg</other_name>
    <other_name>Fluvastatin 80 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given 12h and 2h before CABG.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients on chronic statin treatment (&gt;30 days) scheduled for isolated CABG, including&#xD;
             on- or off-pump or repeat (redo's) revascularisation procedures&#xD;
&#xD;
          2. Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome&#xD;
             (NSTE-ACS)&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
          4. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid&#xD;
             surgery)&#xD;
&#xD;
          2. Acute ST-segment-elevation myocardial infarction (STEMI)&#xD;
&#xD;
          3. NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from&#xD;
             hospital admission&#xD;
&#xD;
          4. History of atrial fibrillation or muscle disease (myopathy)&#xD;
&#xD;
          5. Current renal (creatinine&gt;2x upper limit of normal (ULN), dialysis, kidney transplant)&#xD;
             or hepatic dysfunction (AST/ALT&gt;2x ULN, liver transplant or neoplasm)&#xD;
&#xD;
          6. Inability of oral drug intake&#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>Oliver J Liakopoulos, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cologne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Center Freiburg-Bad Krozingen</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Württemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center Bad Neustadt</name>
      <address>
        <city>Bad Neustadt An Der Saale</city>
        <state>Bayern</state>
        <zip>97616</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Aachen</name>
      <address>
        <city>Aachen</city>
        <state>NRW</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center Bad Oeynhausen</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>NRW</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bochum</name>
      <address>
        <city>Bochum</city>
        <state>NRW</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bonn</name>
      <address>
        <city>Bonn</city>
        <state>NRW</state>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cologne</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Essen</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Muenster</name>
      <address>
        <city>Muenster</city>
        <state>NRW</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Heart Center Wuppertal</name>
      <address>
        <city>Wuppertal</city>
        <state>NRW</state>
        <zip>42117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.start-cabg.de</url>
    <description>StaRT CABG Homepage</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>PD Dr. Oliver J. Liakopoulos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Statins</keyword>
  <keyword>Coronary Artery Bypass Grafting</keyword>
  <keyword>Cardiac Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Simvastatin</mesh_term>
    <mesh_term>Pravastatin</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/NCT01715714
org study id: Uni-Koeln-1341
secondary id: 2011-001795-19
secondary id: DRKS00000753
nct id: NCT01715714
lead sponsor: 
collaborator: 
has dmc: Yes
Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at
      risk for postoperative complications after surgery. The StaRT-CABG trial is the first
      large-scale (2,630 patients) that will investigate whether an additional treatment with
      statins (lipid-lowering medication) in high doses before CABG surgery can reduce the
      incidence of major post-surgery complications including death, myocardial infarction and
      stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in
      Germany and is expected to provide relevant clinical data on the efficacy of this novel
      treatment in order to optimize the care for all patients undergoing CABG.
Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG)
      are still at significant risk for postoperative major adverse cardiocerebral events (≈15%
      MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence
      shows that cardioprotection in patients receiving chronic statin treatment can be further
      improved by a high-dose statin 'recapture' therapy given shortly before an
      ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in
      patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems
      particularly promising, as myocardial injury, surgery-related inflammation and pre-existing
      patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be
      improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale
      (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind
      and placebo-controlled trial that aims to test whether an acute high-dose statin recapture
      therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery
      (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and
      cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical
      data on the efficacy of this novel therapeutic approach in order to optimize the care for all
      CAD patients undergoing CABG with broad clinical implications on current clinical practice
      and existing guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Major adverse cardiocerebral events (MACCE) within 30 days after CABG.
time frame: 30 days after Surgery
description: Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).
measure: Major adverse cardiac events
time frame: 30 days after Surgery
description: Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.
measure: Length of stay
time frame: within the first 15 days after surgery (plus or minus 5 days)
description: Length of stay on intensive care unit (ICU) and hospital
measure: Repeat coronary revascularisation
time frame: 30 days after surgery
description: Repeat coronary revascularisation (PCI or CABG)
measure: Mortality at 12 months
time frame: 12 months after surgery
description: All-cause mortality at 12 months
measure: Wound Infections
time frame: 30 days after surgery
description: Surgical site wound infections.
measure: Atrial fibrillation
time frame: within the first 15 days after surgery (plus or minus 5 days)
description: New-onset postoperative atrial fibrillation
arm group label: Statin Recapture Therapy
arm group type: Active Comparator
description: Oral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin* on admission. (*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo given orally 12 hrs and 2 hrs before CABG
intervention type: Drug
intervention name: Statin Recapture Therapy
description: Given 12h and 2h before CABG
arm group label: Statin Recapture Therapy
other name: Simvastatin 80 mg
other name: Atorvastatin 80 mg
other name: Pravastatin 40 mg
other name: Fluvastatin 80 mg
intervention type: Drug
intervention name: Placebo
description: Given 12h and 2h before CABG.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver J Liakopoulos, MD, PhD
role: Principal Investigator
affiliation: University of Cologne
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: http://www.start-cabg.de
description: StaRT CABG Homepage
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: PD Dr. Oliver J. Liakopoulos
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Atorvastatin
mesh term: Simvastatin
mesh term: Pravastatin