<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/NCT01694459</url>
  </required_header>
  <id_info>
    <org_study_id>596-2012-D</org_study_id>
    <nct_id>NCT01694459</nct_id>
  </id_info>
  <brief_title>DEDICA (Dose of HEparin During Coronary Angioplasty) Trial</brief_title>
  <acronym>DEDICA</acronym>
  <official_title>Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Filippo Neri General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Filippo Neri General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      International guidelines support the use of a full-dose heparin (anticoagulants) during&#xD;
      coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances&#xD;
      in angioplasty techniques and the widespread use of pretreatment with two antiplatelet&#xD;
      agents.&#xD;
&#xD;
      Thus the investigators designed a study comparing safety and efficacy of standard dose&#xD;
      heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty&#xD;
      who are on aspirin and clopidogrel at the time of the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose&#xD;
           heparin. the study will include &quot;all-comers&quot; (patients with either stable angina or&#xD;
           acute coronary syndromes); only patients with ST-elevation myocardial infarction will be&#xD;
           excluded.&#xD;
&#xD;
        -  An ACT (activated clotting time) will be performed after the initial bolus of heparin:&#xD;
           for the standard dose group the target ACT will be &gt; 300 sec. (as recommended by&#xD;
           guidelines) while for the low-dose the target ACT will be &gt; 180 sec.&#xD;
&#xD;
      Aim of the study is to show equivalence in ischemic events between the two doses of heparin,&#xD;
      in order to confirm the safety of lower dose of heparin in contemporary coronary&#xD;
      interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACE + stent thrombosis + major bleeding (TIMI definition)</measure>
    <time_frame>30 days</time_frame>
    <description>MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>30 days</time_frame>
    <description>MACE = death, myocardial infarction, target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Major bleeding according to TIMI criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>30 days</time_frame>
    <description>Stent thrombosis (definite or probable according to ARC criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CK-MB increase</measure>
    <time_frame>30 days</time_frame>
    <description>Any CK MB increase &gt;3 times upper limit of normal or &gt;50% baseline levels (if baseline levels already &gt;then upper limit of normal)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Major bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Major bleeding according to STEEPLE criteria</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Stable Angina</condition>
  <condition>Angina, Unstable</condition>
  <condition>Non-ST Elevation (NSTEMI) Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Standard dose heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) &gt; 300 sec. during the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-dose heparin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bolus of 50 UI/Kg heparin with a target ACT during the procedure of &gt;200 sec.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low-dose heparin</intervention_name>
    <description>Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions</description>
    <arm_group_label>Low-dose heparin</arm_group_label>
    <other_name>50 UI/Kg bolus heparin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard dose heparin</intervention_name>
    <description>Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.</description>
    <arm_group_label>Standard dose heparin</arm_group_label>
    <other_name>100 Ui/Kg bolus heparin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing&#xD;
             coronary angioplasty.&#xD;
&#xD;
          -  Mandatory pretreatment with aspirin and clopidogrel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST elevation myocardial infarction&#xD;
&#xD;
          -  Coronary interventions with rotational atherectomy&#xD;
&#xD;
          -  Coronary interventions on chronic total occlusions (CTO)&#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>Vincenzo Pasceri, MD</last_name>
    <role>Study Chair</role>
    <affiliation>San Filippo Neri Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesco Pelliccia, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincenzo Pasceri, MD</last_name>
    <phone>+39063306</phone>
    <phone_ext>2504</phone_ext>
    <email>vpasceri@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francesco Pelliccia, MD</last_name>
    <phone>+393483392006</phone>
    <email>md4151@mclink.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Rome La Sapienza</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Pelliccia, MD</last_name>
    </contact>
    <investigator>
      <last_name>Carlo Gaudio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 26, 2012</last_update_submitted>
  <last_update_submitted_qc>September 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Filippo Neri General Hospital</investigator_affiliation>
    <investigator_full_name>Vincenzo Pasceri</investigator_full_name>
    <investigator_title>Attending Cardiologist</investigator_title>
  </responsible_party>
  <keyword>angioplasty</keyword>
  <keyword>heparin</keyword>
  <keyword>trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</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/NCT01694459
org study id: 596-2012-D
nct id: NCT01694459
lead sponsor: 
collaborator: 
has dmc: No
International guidelines support the use of a full-dose heparin (anticoagulants) during
      coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances
      in angioplasty techniques and the widespread use of pretreatment with two antiplatelet
      agents.

      Thus the investigators designed a study comparing safety and efficacy of standard dose
      heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty
      who are on aspirin and clopidogrel at the time of the procedure.
-  Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose
           heparin. the study will include "all-comers" (patients with either stable angina or
           acute coronary syndromes); only patients with ST-elevation myocardial infarction will be
           excluded.

        -  An ACT (activated clotting time) will be performed after the initial bolus of heparin:
           for the standard dose group the target ACT will be > 300 sec. (as recommended by
           guidelines) while for the low-dose the target ACT will be > 180 sec.

      Aim of the study is to show equivalence in ischemic events between the two doses of heparin,
      in order to confirm the safety of lower dose of heparin in contemporary coronary
      interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: MACE + stent thrombosis + major bleeding (TIMI definition)
time frame: 30 days
description: MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
measure: MACE
time frame: 30 days
description: MACE = death, myocardial infarction, target vessel revascularization
measure: Major Bleeding
time frame: 30 days
description: Major bleeding according to TIMI criteria
measure: Stent thrombosis
time frame: 30 days
description: Stent thrombosis (definite or probable according to ARC criteria)
measure: CK-MB increase
time frame: 30 days
description: Any CK MB increase >3 times upper limit of normal or >50% baseline levels (if baseline levels already >then upper limit of normal)
measure: Major bleeding
time frame: 30 days
description: Major bleeding according to STEEPLE criteria
arm group label: Standard dose heparin
arm group type: Active Comparator
description: Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure
arm group label: Low-dose heparin
arm group type: Experimental
description: Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec.
intervention type: Drug
intervention name: Low-dose heparin
description: Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
arm group label: Low-dose heparin
other name: 50 UI/Kg bolus heparin
intervention type: Drug
intervention name: Standard dose heparin
description: Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
arm group label: Standard dose heparin
other name: 100 Ui/Kg bolus heparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincenzo Pasceri, MD
role: Study Chair
affiliation: San Filippo Neri Hospital
last name: Francesco Pelliccia, MD
role: Study Director
affiliation: University of Roma La Sapienza
last name: Vincenzo Pasceri, MD
phone: +39063306
phone ext: 2504
email: vpasceri@hotmail.com
last name: Francesco Pelliccia, MD
phone: +393483392006
email: md4151@mclink.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: San Filippo Neri General Hospital
investigator full name: Vincenzo Pasceri
investigator title: Attending Cardiologist
mesh term: Myocardial Infarction
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Angina, Unstable
mesh term: Infarction
mesh term: Heparin
mesh term: Calcium heparin