<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/NCT02251249</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/19</org_study_id>
    <nct_id>NCT02251249</nct_id>
  </id_info>
  <brief_title>Impairment of Gastric Emptying During Acute Phase of Myocardial Infarction. Impact on Oral Antiplatelet Treatment Efficacy. The GASTRIM Study.</brief_title>
  <acronym>GASTRIM</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial&#xD;
      infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric&#xD;
      emptying time is observed during STEMI, limiting the use of morphine and encourage the use of&#xD;
      prokinetic agents can be a first answer to optimize coronary angioplasty environment.&#xD;
&#xD;
      Investigators propose a study to assess the gastric emptying times at the acute phase of&#xD;
      myocardial infarction using a validated paracetamol absorption test. The STEMI group will be&#xD;
      compared to in one hand, itself with measures performed 72 hours±12h after the event onset;&#xD;
      and on the other hand, to a stable patient group referred for angioplasty for angina or&#xD;
      non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient&#xD;
      group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by&#xD;
      VerifyNow® test and correlated to gastric emptying times.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial&#xD;
      infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric&#xD;
      emptying time is observed during STEMI, limiting the use of morphine and encourage the use of&#xD;
      prokinetic agents can be a first answer to optimize coronary angioplasty environment.&#xD;
&#xD;
      Investigators propose a study to assess the gastric emptying times at the acute phase of&#xD;
      myocardial infarction using a validated paracetamol absorption test. The STEMI group will be&#xD;
      compared to in one hand, itself with measures performed 72 hours±12h after the event onset;&#xD;
      and on the other hand, to a stable patient group referred for angioplasty for angina or&#xD;
      non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient&#xD;
      group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by&#xD;
      VerifyNow® test and correlated to gastric emptying times.&#xD;
&#xD;
      Paracetamol absorption test is a safe, cheap and well validated method to assess these times&#xD;
      including during the STEMI period. This one consists in oral ingestion of 1.5g of paracetamol&#xD;
      followed by the realization of the curve of concentration of paracetamol in plasma samples.&#xD;
      These samples are taken at 15 min intervals during the first 2 hours.&#xD;
&#xD;
      In the same time the curve of Platelet reactivity Unit (PRU) obtained by VerifyNow® tests&#xD;
      will be determined with the goal to establish a relation between gastric emptying times and&#xD;
      delayed observed antiplatelet activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Actual">September 25, 2016</completion_date>
  <primary_completion_date type="Actual">September 25, 2016</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of the paracetamol concentration time curve at the time of STEMI Onset</measure>
    <time_frame>Every 15 minutes since inclusion (STEMI onset ) up to 120 minutes</time_frame>
    <description>Taking of blood samples every 15 minutes for patients of STEMI Group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the paracetamol concentration time curve 72 hours after time of STEMI Onset</measure>
    <time_frame>Every 15 minutes since 72 hours after STEMI onset up to 120 minutes</time_frame>
    <description>Taking of blood samples every 15 minutes for patients of STEMI Group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the paracetamol concentration time curve for Stable patient Group</measure>
    <time_frame>Every 15 minutes since inclusion up to 120 minutes</time_frame>
    <description>Taking of blood samples every 15 minutes for Stable patient Group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Impairment of Gastric Emptying</condition>
  <condition>Acute Phase of Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>STEMI Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stable patient Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol concentration time curve from 0 to 120 min</intervention_name>
    <description>It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets Brilique ® 90 mg) with water. Then Paracetamol concentration is followed by the realization of the curve of concentration of paracetamol in plasma samples. These samples are taken at 15 min intervals during the first 2 hours.</description>
    <arm_group_label>STEMI Group</arm_group_label>
    <arm_group_label>Stable patient Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years weighing between 65 and 85 Kg&#xD;
&#xD;
          -  Referred for STEMI within 6 hours from beginning of chest pain or stable coronary&#xD;
             artery disease requiring a loading dose of Prasugrel or Ticagrelor according to the&#xD;
             international recommendations.&#xD;
&#xD;
          -  No previous treatment with Clopidogrel, Prasugrel or Ticagrelor.&#xD;
&#xD;
          -  Patient fasting for at least 6 hours.&#xD;
&#xD;
          -  Affiliate or receiving a social security system.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or contraindication to paracetamol, Prasugrel or Ticagrelor&#xD;
&#xD;
          -  Paracetamol ingestion in the previous 48 hours&#xD;
&#xD;
          -  Patient treated with drugs supposed to alter gastric emptying times (calcium&#xD;
             antagonists, Alimentary tract treatments, opioid analgesics, tricyclic&#xD;
             antidepressants, antibiotics).&#xD;
&#xD;
          -  Conditions or pathologies supposed to alter gastric emptying times (Thyroid&#xD;
             dysfunction, chronic renal failure, Parkinson's disease, scleroderma, amyloidosis, any&#xD;
             gastrointestinal disease, any not cured malignancy, and any advanced psychiatric or&#xD;
             neurological disease).&#xD;
&#xD;
          -  Presence of vomiting&#xD;
&#xD;
          -  Cardiogenic shock, ventricular arrhythmia or resuscitated cardiac arrest&#xD;
&#xD;
          -  Hepatic insufficiency&#xD;
&#xD;
          -  Severe respiratory disease&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Bordeaux - Hôpital du Haut Lévèque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</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/NCT02251249
org study id: CHUBX 2013/19
nct id: NCT02251249
lead sponsor: 
has dmc: No
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial
      infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric
      emptying time is observed during STEMI, limiting the use of morphine and encourage the use of
      prokinetic agents can be a first answer to optimize coronary angioplasty environment.

      Investigators propose a study to assess the gastric emptying times at the acute phase of
      myocardial infarction using a validated paracetamol absorption test. The STEMI group will be
      compared to in one hand, itself with measures performed 72 hours±12h after the event onset;
      and on the other hand, to a stable patient group referred for angioplasty for angina or
      non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient
      group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by
      VerifyNow® test and correlated to gastric emptying times.
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial
      infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric
      emptying time is observed during STEMI, limiting the use of morphine and encourage the use of
      prokinetic agents can be a first answer to optimize coronary angioplasty environment.

      Investigators propose a study to assess the gastric emptying times at the acute phase of
      myocardial infarction using a validated paracetamol absorption test. The STEMI group will be
      compared to in one hand, itself with measures performed 72 hours±12h after the event onset;
      and on the other hand, to a stable patient group referred for angioplasty for angina or
      non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient
      group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by
      VerifyNow® test and correlated to gastric emptying times.

      Paracetamol absorption test is a safe, cheap and well validated method to assess these times
      including during the STEMI period. This one consists in oral ingestion of 1.5g of paracetamol
      followed by the realization of the curve of concentration of paracetamol in plasma samples.
      These samples are taken at 15 min intervals during the first 2 hours.

      In the same time the curve of Platelet reactivity Unit (PRU) obtained by VerifyNow® tests
      will be determined with the goal to establish a relation between gastric emptying times and
      delayed observed antiplatelet activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Determination of the paracetamol concentration time curve at the time of STEMI Onset
time frame: Every 15 minutes since inclusion (STEMI onset ) up to 120 minutes
description: Taking of blood samples every 15 minutes for patients of STEMI Group
measure: Determination of the paracetamol concentration time curve 72 hours after time of STEMI Onset
time frame: Every 15 minutes since 72 hours after STEMI onset up to 120 minutes
description: Taking of blood samples every 15 minutes for patients of STEMI Group
measure: Determination of the paracetamol concentration time curve for Stable patient Group
time frame: Every 15 minutes since inclusion up to 120 minutes
description: Taking of blood samples every 15 minutes for Stable patient Group
arm group label: STEMI Group
arm group type: Experimental
arm group label: Stable patient Group
arm group type: Other
description: Patient referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI)
intervention type: Drug
intervention name: Paracetamol concentration time curve from 0 to 120 min
description: It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets Brilique ® 90 mg) with water. Then Paracetamol concentration is followed by the realization of the curve of concentration of paracetamol in plasma samples. These samples are taken at 15 min intervals during the first 2 hours.
arm group label: STEMI Group
arm group label: Stable patient Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Acetaminophen