<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/NCT02243137</url>
  </required_header>
  <id_info>
    <org_study_id>2012-ECCLIPSE-01</org_study_id>
    <secondary_id>2012-001702-20</secondary_id>
    <nct_id>NCT02243137</nct_id>
  </id_info>
  <brief_title>Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate</brief_title>
  <acronym>ECCLIPSE</acronym>
  <official_title>Effects of Combinated Administration of Lysine Acetylsalicylate Versus Prasugrel and Aspirin on Platelet Aggregation in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Vivas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Carlos Hospital, Madrid, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Investigacion Interhospitalaria Cardiovascular</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I clinical trial in healthy volunteers comparing the effect of lysine&#xD;
      acetylsalicylate or aspirin on platelet function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs&#xD;
      1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology&#xD;
      Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330&#xD;
      31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.3. Clinical trial title Effect of&#xD;
      combined administration of prasugrel and lysine acetylsalicylate intravenously versus&#xD;
      prasugrel and aspirin on platelet aggregation in healthy volunteers (ECCLIPSE trial).&#xD;
&#xD;
      1.4. Protocol code Nº EudraCT: 2012-001702-20 Code: 2012-ECCLIPSE-01 Version: V3 Date:&#xD;
      13/04/2012&#xD;
&#xD;
      1.5. Project principal investigator Dr. David Vivas Balcones Cardiology Department Hospital&#xD;
      Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34&#xD;
      913303142 Email: dvivas@secardiologia.es 1.6. Centers Investigators&#xD;
&#xD;
      San Carlos University Hospital (Madrid). Within the following services and researchers are&#xD;
      involved:&#xD;
&#xD;
      Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid&#xD;
      Teléfono: +34 91 330 31 49 Fax: +34 913303142 Project principal investigator and Promoter:&#xD;
      Dr. David Vivas Balcones Co-Investigators: Dr. Agustín Martín, Dr. Isidre Vilacosta, Dr. Iván&#xD;
      Núñez-Gil y Dr. Carlos Macaya&#xD;
&#xD;
      Platelet function laboratory Cardiology Department Hospital Clínico San Carlos C/Prof Martín&#xD;
      Lagos SN 28040 Madrid Phone: +34 913307260 Fax: +34 913303142 Co-Investigators: Dr. Antonio&#xD;
      Fernández-Ortiz, Esther Bernardo y María Aranzazu Ortega Pozzi&#xD;
&#xD;
      Clinical Trials Unit (CEIC) Biomedical Research Foundation Hospital Clínico San Carlos C/&#xD;
      Prof. Martín Lagos S/N 28040 Madrid Phone: + 34 913303793 Fax: +34 913303515 Co-Investigator:&#xD;
      Dra. Saioa Alonso&#xD;
&#xD;
      Clinical Research Ethics Committee The Clinical Research Ethics Committee (CEIC) charged with&#xD;
      assessing the project will be the CEIC of the San Carlos University Hospital.&#xD;
&#xD;
      1.7. Responsible for Monitoring: MEDITRIALS 1.8. Experimental and control drug • Experimental&#xD;
      group: Loading dose (LD) of intravenous lysine acetylsalicylate 450 mg and prasugrel 60 mg&#xD;
      orally.&#xD;
&#xD;
      • Control group: Loading dose (LD) of aspirin 300 mg orally and prasugrel 60 mg orally. Being&#xD;
      a crossover study, subjects will receive both treatment arms in the two treatment periods&#xD;
      with a gap of 15 days (washout period) between the two administrations.&#xD;
&#xD;
      1.9. Study endpoints Primary endpoint To compare the inhibition of platelet aggregation (IPA)&#xD;
      at 30 minutes after administration of prasugrel loading dose in association with intravenous&#xD;
      lysine acetylsalicylate versus prasugrel plus aspirin.&#xD;
&#xD;
      Secundary endpoints To compare the inhibition of platelet aggregation (IPA) at 0 (baseline),&#xD;
      1, 4 and 24 hours after the administration of both treatment groups.&#xD;
&#xD;
      To compare the inhibition of platelet reactivity (IPR) throughout the time period in both&#xD;
      treatment groups.&#xD;
&#xD;
      To evaluate the safety of the treatment administered.&#xD;
&#xD;
      1.10. Study design The ECCLIPSE study is a phase I, randomized, single center, open,&#xD;
      two-period crossover trial in each of which subjects receive a single dose of certain drugs&#xD;
      in each treatment group.&#xD;
&#xD;
      1.11. Pathology study None. 1.12. Population and sample size The study population will be&#xD;
      healthy volunteers (total 30 subjects). This is a pharmacodynamic study, with subsequent&#xD;
      extrapolation of findings to patients with acute coronary syndrome 1.13. Duration of&#xD;
      treatment In each period of treatment, subjects will received a single dose of drugs&#xD;
      determined in each treatment arm and the analysis of the parameters under study will be&#xD;
      processed over the next 24 hours. After the two weeks washout period, subjects will receive&#xD;
      the other study drug regimen in a single dose and it will take place the analysis within 24&#xD;
      hours of the parameters studied.&#xD;
&#xD;
      1.14. Primary variable Inhibition of platelet aggregation measured by light transmission&#xD;
      aggregometry at 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inhibition of platelet aggregation</measure>
    <time_frame>at 30 minutes</time_frame>
    <description>measured by light transmission aggregometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet aggregation</measure>
    <time_frame>baseline, 1 h, 4 h and 34 h</time_frame>
    <description>measured by light transmission aggregometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet reactivity</measure>
    <time_frame>baseline, 1 h, 4 h and 34 h</time_frame>
    <description>by the platelet reactivity index (PRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>baseline, 30 min, 1 h, 4 h, and 24 h</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Adverse Effect of Antithrombotic Drugs</condition>
  <arm_group>
    <arm_group_label>prasugrel and acetylsalicylic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lysine acetylsalicylate and prasugrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetylsalicylic acid</intervention_name>
    <description>Administration: one dose of Acetylsalicylic Acid (300mg)</description>
    <arm_group_label>prasugrel and acetylsalicylic</arm_group_label>
    <other_name>Adiro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prasugrel</intervention_name>
    <description>Administration: one loading dose (60mg)</description>
    <arm_group_label>lysine acetylsalicylate and prasugrel</arm_group_label>
    <arm_group_label>prasugrel and acetylsalicylic</arm_group_label>
    <other_name>Effient</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lysine acetylsalicylate</intervention_name>
    <description>Administration: one dose (450mg iv)</description>
    <arm_group_label>lysine acetylsalicylate and prasugrel</arm_group_label>
    <other_name>Inyesprin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60 years.&#xD;
&#xD;
          -  BMI&gt; 19kg/m2 and &lt;29kg/m2.&#xD;
&#xD;
          -  Women of childbearing potential who are committed to use a medically effective&#xD;
             contraception during their participation in the study, except hormonal contraceptives.&#xD;
&#xD;
          -  Percentage of inhibition of platelet aggregation after stimulation with high basal 20&#xD;
             mM ADP and arachidonic acid 1.5 mM&gt; 70%.&#xD;
&#xD;
          -  No clinically significant deviation on physical examination, ECG or laboratory values&#xD;
             in laboratory tests.&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Infection with Hepatitis B or C, or HIV&#xD;
&#xD;
          -  Known drug allergies&#xD;
&#xD;
          -  Family history of blood disorders or coagulation.&#xD;
&#xD;
          -  History of disease that alters the absorption, metabolism or excretion of drugs,&#xD;
             including jaundice.&#xD;
&#xD;
          -  Personal history of bleeding and / or blood dyscrasias (especially hemophilia,&#xD;
             hypoprothrombinemia), including vascular malformations reasonable suspicion.&#xD;
&#xD;
          -  History of any medically relevant condition&#xD;
&#xD;
          -  Background of major surgery in the last 3 months&#xD;
&#xD;
          -  Prescription of chronic medication in the 14 days prior to study participation.&#xD;
&#xD;
          -  Participation in another study involving the administration of an investigational&#xD;
             product in the last 4 months or a product already on the market in the last three&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Vivas, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Carlos University Hospital, Madrid Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>June 24, 2013</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Investigacion Interhospitalaria Cardiovascular</investigator_affiliation>
    <investigator_full_name>David Vivas</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Acetylsalicylic acid lysinate</mesh_term>
    <mesh_term>Prasugrel Hydrochloride</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/NCT02243137
org study id: 2012-ECCLIPSE-01
secondary id: 2012-001702-20
nct id: NCT02243137
lead sponsor: 
collaborator: 
has dmc: No
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine
      acetylsalicylate or aspirin on platelet function.
1. SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs
      1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology
      Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330
      31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.3. Clinical trial title Effect of
      combined administration of prasugrel and lysine acetylsalicylate intravenously versus
      prasugrel and aspirin on platelet aggregation in healthy volunteers (ECCLIPSE trial).

      1.4. Protocol code Nº EudraCT: 2012-001702-20 Code: 2012-ECCLIPSE-01 Version: V3 Date:
      13/04/2012

      1.5. Project principal investigator Dr. David Vivas Balcones Cardiology Department Hospital
      Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34
      913303142 Email: dvivas@secardiologia.es 1.6. Centers Investigators

      San Carlos University Hospital (Madrid). Within the following services and researchers are
      involved:

      Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid
      Teléfono: +34 91 330 31 49 Fax: +34 913303142 Project principal investigator and Promoter:
      Dr. David Vivas Balcones Co-Investigators: Dr. Agustín Martín, Dr. Isidre Vilacosta, Dr. Iván
      Núñez-Gil y Dr. Carlos Macaya

      Platelet function laboratory Cardiology Department Hospital Clínico San Carlos C/Prof Martín
      Lagos SN 28040 Madrid Phone: +34 913307260 Fax: +34 913303142 Co-Investigators: Dr. Antonio
      Fernández-Ortiz, Esther Bernardo y María Aranzazu Ortega Pozzi

      Clinical Trials Unit (CEIC) Biomedical Research Foundation Hospital Clínico San Carlos C/
      Prof. Martín Lagos S/N 28040 Madrid Phone: + 34 913303793 Fax: +34 913303515 Co-Investigator:
      Dra. Saioa Alonso

      Clinical Research Ethics Committee The Clinical Research Ethics Committee (CEIC) charged with
      assessing the project will be the CEIC of the San Carlos University Hospital.

      1.7. Responsible for Monitoring: MEDITRIALS 1.8. Experimental and control drug • Experimental
      group: Loading dose (LD) of intravenous lysine acetylsalicylate 450 mg and prasugrel 60 mg
      orally.

      • Control group: Loading dose (LD) of aspirin 300 mg orally and prasugrel 60 mg orally. Being
      a crossover study, subjects will receive both treatment arms in the two treatment periods
      with a gap of 15 days (washout period) between the two administrations.

      1.9. Study endpoints Primary endpoint To compare the inhibition of platelet aggregation (IPA)
      at 30 minutes after administration of prasugrel loading dose in association with intravenous
      lysine acetylsalicylate versus prasugrel plus aspirin.

      Secundary endpoints To compare the inhibition of platelet aggregation (IPA) at 0 (baseline),
      1, 4 and 24 hours after the administration of both treatment groups.

      To compare the inhibition of platelet reactivity (IPR) throughout the time period in both
      treatment groups.

      To evaluate the safety of the treatment administered.

      1.10. Study design The ECCLIPSE study is a phase I, randomized, single center, open,
      two-period crossover trial in each of which subjects receive a single dose of certain drugs
      in each treatment group.

      1.11. Pathology study None. 1.12. Population and sample size The study population will be
      healthy volunteers (total 30 subjects). This is a pharmacodynamic study, with subsequent
      extrapolation of findings to patients with acute coronary syndrome 1.13. Duration of
      treatment In each period of treatment, subjects will received a single dose of drugs
      determined in each treatment arm and the analysis of the parameters under study will be
      processed over the next 24 hours. After the two weeks washout period, subjects will receive
      the other study drug regimen in a single dose and it will take place the analysis within 24
      hours of the parameters studied.

      1.14. Primary variable Inhibition of platelet aggregation measured by light transmission
      aggregometry at 30 minutes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Inhibition of platelet aggregation
time frame: at 30 minutes
description: measured by light transmission aggregometry
measure: Inhibition of platelet aggregation
time frame: baseline, 1 h, 4 h and 34 h
description: measured by light transmission aggregometry
measure: Inhibition of platelet reactivity
time frame: baseline, 1 h, 4 h and 34 h
description: by the platelet reactivity index (PRI)
measure: Incidence of adverse events
time frame: baseline, 30 min, 1 h, 4 h, and 24 h
arm group label: prasugrel and acetylsalicylic
arm group type: Active Comparator
description: single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally
arm group label: lysine acetylsalicylate and prasugrel
arm group type: Experimental
description: single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous
intervention type: Drug
intervention name: acetylsalicylic acid
description: Administration: one dose of Acetylsalicylic Acid (300mg)
arm group label: prasugrel and acetylsalicylic
other name: Adiro
intervention type: Drug
intervention name: prasugrel
description: Administration: one loading dose (60mg)
arm group label: lysine acetylsalicylate and prasugrel
arm group label: prasugrel and acetylsalicylic
other name: Effient
intervention type: Drug
intervention name: lysine acetylsalicylate
description: Administration: one dose (450mg iv)
arm group label: lysine acetylsalicylate and prasugrel
other name: Inyesprin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Vivas, MD, PhD
role: Principal Investigator
affiliation: San Carlos University Hospital, Madrid Spain
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Investigacion Interhospitalaria Cardiovascular
investigator full name: David Vivas
investigator title: MD, PhD
mesh term: Aspirin
mesh term: Acetylsalicylic acid lysinate
mesh term: Prasugrel Hydrochloride