<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/NCT01735227</url>
  </required_header>
  <id_info>
    <org_study_id>NH2012-9-20</org_study_id>
    <nct_id>NCT01735227</nct_id>
  </id_info>
  <brief_title>Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)</brief_title>
  <official_title>Single-center Randomized Controlled Study of Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Randomized Controlled Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yaling Han</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenyang Northern Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,&#xD;
      the investigators designed a clinical randomized controlled trials of omeprazole and&#xD;
      pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have&#xD;
      taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly&#xD;
      divided into omeprazole and pantoprazole groups . On the day of admission , all patients&#xD;
      taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of&#xD;
      clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,&#xD;
      pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (&#xD;
      before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each&#xD;
      taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet&#xD;
      aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical&#xD;
      adverse events ( including death , myocardial infarction , and any revascularization , stent&#xD;
      thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding&#xD;
      events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year&#xD;
      follow-up results , and further explore the optimal combination of dual anti-platelet and&#xD;
      joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable&#xD;
      for clinical programs to create a personalized treatment system , improve the patient's&#xD;
      quality of life .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through a number of large-scale clinical trials , Meta analysis, and clinical treatment&#xD;
      guidelines confirm that clopidogrel and aspirin dual antiplatelet treatment strategies for&#xD;
      acute coronary syndrome (ACS) undergoing percutaneous coronary interventions(PCI) of stent&#xD;
      implantation surgery patients have a vital role . It can effectively suppress acute 、subacute&#xD;
      stent thrombosis formation , reduce readmissions ratio , thus greatly improving the quality&#xD;
      of life of patients . A large number of clinical practice reports, although the treatment&#xD;
      strategies to reduce the incidence of adverse cardiovascular events ,it has increased the&#xD;
      possibility of the occurrence of gastrointestinal bleeding complications . Proton pump&#xD;
      inhibitors (PPIs) are often used to prevent gastrointestinal complications of dual&#xD;
      antiplatelet therapy . 2008 American College of Cardiology (ACC) / American Society of&#xD;
      Gastroenterology (ACG) / American Heart Association (AHA) jointly issued a consensus document&#xD;
      , consistently recommended that the majority of clinicians application of dual antiplatelet&#xD;
      and PPIs treatment for patients with risk factors for gastrointestinal bleeding that may&#xD;
      exist at the same time ,in order to reduce the occurrence of gastrointestinal adverse events&#xD;
      . But at home and abroad in recent years, there have been reports suggest that the&#xD;
      interaction of PPIs with clopidogrel may exist , thereby reduce the latter 's anti- platelet&#xD;
      effect , in order to make the incidence of adverse CV events increased about 25-64 % . In&#xD;
      January 2009 , the U.S. Food and Drug Administration (FDA) announced a safety review of an&#xD;
      earlier report on the potential interaction of these two types drugs , particularly stressed&#xD;
      the need to carry out a large number of clinical practice research further to clear both the&#xD;
      interaction . PPIs antiplatelet effects of clopidogrel after PCI is not yet very clear ,&#xD;
      clinical results on both interactions still exist many different academic perspectives and&#xD;
      research defects , so still need to arouse sufficient attention , continue to carry out the&#xD;
      relevant fields research .&#xD;
&#xD;
      In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,&#xD;
      the investigators designed a clinical randomized controlled trials of omeprazole and&#xD;
      pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigator have&#xD;
      taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly&#xD;
      divided into omeprazole and pantoprazole groups . On the day of admission , all patients&#xD;
      taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of&#xD;
      clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,&#xD;
      pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (&#xD;
      before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each&#xD;
      taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet&#xD;
      aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical&#xD;
      adverse events ( including death , myocardial infarction , and any revascularization , stent&#xD;
      thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding&#xD;
      events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year&#xD;
      follow-up results , and further explore the optimal combination of dual anti-platelet and&#xD;
      joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable&#xD;
      for clinical programs to create a personalized treatment system , improve the patient's&#xD;
      quality of life .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet aggregation rate(AA 、ADP)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>MACE(including cardiac death, acute myocardial infarction , target lesion revascularization , shock);&#xD;
stent thrombosis;&#xD;
stroke</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">620</enrollment>
  <condition>Acute Coronary Syndromes</condition>
  <arm_group>
    <arm_group_label>omeprazole group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>omeprazole group:all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and taking omeprazole 20mg/d(1 month).on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding events) .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pantoprazole group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pantoprazole group: all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term),taking pantoprazole 20mg/d(1 month).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omeprazole</intervention_name>
    <description>all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and omeprazole group taking omeprazole 20mg/d</description>
    <arm_group_label>omeprazole group</arm_group_label>
    <arm_group_label>pantoprazole group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>On the day of admission , all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d , pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization</description>
    <arm_group_label>omeprazole group</arm_group_label>
    <arm_group_label>pantoprazole group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ACS (including unstable angina pectoris, non-ST-segment elevation myocardial&#xD;
             infarction and ST-elevation myocardial infarction) ;&#xD;
&#xD;
          2. The age between18 and 75 ;&#xD;
&#xD;
          3. Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receiving GP IIb / IIIa receptor antagonist treatment;&#xD;
&#xD;
          2. Had received prior to enrollment 7d cilostazol;&#xD;
&#xD;
          3. Dual antiplatelet therapy contraindications;&#xD;
&#xD;
          4. NYHA grade III ~ IV;&#xD;
&#xD;
          5. Presence of multivessel severe coronary lesions , need elective coronary&#xD;
             revascularization;&#xD;
&#xD;
          6. The need for long-term use of warfarin after valve surgery or persistent atrial&#xD;
             fibrillation;&#xD;
&#xD;
          7. Severe liver or kidney dysfunction;&#xD;
&#xD;
          8. Has not been cured of peptic ulcer or presence of bleeding tendency;&#xD;
&#xD;
          9. Who complicate the known bleeding tendency and blood system diseases;&#xD;
&#xD;
         10. Have a history of intracranial hemorrhage within 6 monhs;&#xD;
&#xD;
         11. Planned surgery recently;&#xD;
&#xD;
         12. Pregnancy;&#xD;
&#xD;
         13. Other serious illness, life expectancy less than 6 months;&#xD;
&#xD;
         14. Nearly 1 year underwent PCI , regular take aspirin 、clopidogrel since;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han Yaling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenyang Northern Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Han Yaling, MD</last_name>
    <phone>+86-024-28897309</phone>
    <email>lijing790126@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>OPEN trail</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Han Yaling, MD</last_name>
      <phone>+86-24-28897309</phone>
      <email>lijing790126@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ShenyangNH</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Han Yaling MD</last_name>
      <phone>+86-24-23922184</phone>
      <email>hanyaling@263.net</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shenyang Northern Hospital</investigator_affiliation>
    <investigator_full_name>Yaling Han</investigator_full_name>
    <investigator_title>vice president</investigator_title>
  </responsible_party>
  <keyword>pantoprazole</keyword>
  <keyword>omeprazole</keyword>
  <keyword>anti - platelet effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omeprazole</mesh_term>
    <mesh_term>Pantoprazole</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/NCT01735227
org study id: NH2012-9-20
nct id: NCT01735227
lead sponsor: 
has dmc: Yes
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,
      the investigators designed a clinical randomized controlled trials of omeprazole and
      pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have
      taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly
      divided into omeprazole and pantoprazole groups . On the day of admission , all patients
      taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of
      clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,
      pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (
      before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each
      taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet
      aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical
      adverse events ( including death , myocardial infarction , and any revascularization , stent
      thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding
      events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year
      follow-up results , and further explore the optimal combination of dual anti-platelet and
      joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable
      for clinical programs to create a personalized treatment system , improve the patient's
      quality of life .
Through a number of large-scale clinical trials , Meta analysis, and clinical treatment
      guidelines confirm that clopidogrel and aspirin dual antiplatelet treatment strategies for
      acute coronary syndrome (ACS) undergoing percutaneous coronary interventions(PCI) of stent
      implantation surgery patients have a vital role . It can effectively suppress acute 、subacute
      stent thrombosis formation , reduce readmissions ratio , thus greatly improving the quality
      of life of patients . A large number of clinical practice reports, although the treatment
      strategies to reduce the incidence of adverse cardiovascular events ,it has increased the
      possibility of the occurrence of gastrointestinal bleeding complications . Proton pump
      inhibitors (PPIs) are often used to prevent gastrointestinal complications of dual
      antiplatelet therapy . 2008 American College of Cardiology (ACC) / American Society of
      Gastroenterology (ACG) / American Heart Association (AHA) jointly issued a consensus document
      , consistently recommended that the majority of clinicians application of dual antiplatelet
      and PPIs treatment for patients with risk factors for gastrointestinal bleeding that may
      exist at the same time ,in order to reduce the occurrence of gastrointestinal adverse events
      . But at home and abroad in recent years, there have been reports suggest that the
      interaction of PPIs with clopidogrel may exist , thereby reduce the latter 's anti- platelet
      effect , in order to make the incidence of adverse CV events increased about 25-64 % . In
      January 2009 , the U.S. Food and Drug Administration (FDA) announced a safety review of an
      earlier report on the potential interaction of these two types drugs , particularly stressed
      the need to carry out a large number of clinical practice research further to clear both the
      interaction . PPIs antiplatelet effects of clopidogrel after PCI is not yet very clear ,
      clinical results on both interactions still exist many different academic perspectives and
      research defects , so still need to arouse sufficient attention , continue to carry out the
      relevant fields research .

      In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,
      the investigators designed a clinical randomized controlled trials of omeprazole and
      pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigator have
      taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly
      divided into omeprazole and pantoprazole groups . On the day of admission , all patients
      taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of
      clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,
      pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (
      before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each
      taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet
      aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical
      adverse events ( including death , myocardial infarction , and any revascularization , stent
      thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding
      events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year
      follow-up results , and further explore the optimal combination of dual anti-platelet and
      joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable
      for clinical programs to create a personalized treatment system , improve the patient's
      quality of life .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Platelet aggregation rate(AA 、ADP)
time frame: 30 days
measure: clinical adverse events
time frame: 12 months
description: MACE(including cardiac death, acute myocardial infarction , target lesion revascularization , shock);
stent thrombosis;
stroke
arm group label: omeprazole group
arm group type: Experimental
description: omeprazole group:all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and taking omeprazole 20mg/d(1 month).on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding events) .
arm group label: pantoprazole group
arm group type: Experimental
description: pantoprazole group: all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term),taking pantoprazole 20mg/d(1 month).
intervention type: Drug
intervention name: omeprazole
description: all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and omeprazole group taking omeprazole 20mg/d
arm group label: omeprazole group
arm group label: pantoprazole group
intervention type: Drug
intervention name: Pantoprazole
description: On the day of admission , all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d , pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization
arm group label: omeprazole group
arm group label: pantoprazole group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Han Yaling, MD
role: Principal Investigator
affiliation: Shenyang Northern Hospital
last name: Han Yaling, MD
phone: +86-024-28897309
email: lijing790126@sina.com
facility: 
contact: 
facility: 
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Yaling Han
investigator title: vice president
mesh term: Acute Coronary Syndrome
mesh term: Omeprazole
mesh term: Pantoprazole