<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/NCT04416581</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2020-05</org_study_id>
    <nct_id>NCT04416581</nct_id>
  </id_info>
  <brief_title>Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy</brief_title>
  <acronym>PROTECT-HBR</acronym>
  <official_title>A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duk-Woo Park, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to evaluate the efficacy and safety of P-CAB (tegoprazan 50&#xD;
      mg once daily) as compared with PPI (rabeprazole 20 mg once daily) for protection of GI&#xD;
      events in patients with cardiovascular disease receiving antiplatelet and oral anticoagulant&#xD;
      therapy who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental&#xD;
      arm) is non-inferior to PPI (standard arm) with respect to the rate of the primary composite&#xD;
      endpoint of GI events at 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to&#xD;
      perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure&#xD;
      the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be&#xD;
      included in the data set used for primary analyses.&#xD;
&#xD;
      The safety of tegoprazan will be estimated SIAEs(Special Interest Adverse Events) as follows;&#xD;
      Composite Event&#xD;
&#xD;
        1. liver function abnormalities&#xD;
&#xD;
        2. hypergastrinemia, or&#xD;
&#xD;
        3. enteric infection&#xD;
&#xD;
      Definitions&#xD;
&#xD;
        -  liver function abnormality: defined as AST or ALT&gt;3× upper limit of normal or two&#xD;
           consecutive measurements of total bilirubin &gt;2 x upper limit of normal&#xD;
&#xD;
        -  hypergastrinemia&#xD;
&#xD;
        -  enteric infection including C.difficile infection&#xD;
&#xD;
      If there are any new tegoprazan-related findings, it will be considered in the estimation.&#xD;
&#xD;
      If there is no safety concern during safety surveillance phase, investigator-driven,&#xD;
      randomized, double-blind, double-dummy, active-controlled, clinical trial (N = 2,600&#xD;
      patients) will be subsequently performed (randomization phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 12, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period (which was defined as the time from the first administration of a trial drug through 6 months of therapy)</measure>
    <time_frame>12 months</time_frame>
    <description>This composite outcome included:&#xD;
Overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography);&#xD;
Overt upper gastrointestinal bleeding of unknown origin;&#xD;
Bleeding of presumed occult gastrointestinal origin with a documented decrease in haemoglobin of ≥ 2 g/dL or decrease in hematocrit ≥ 10% from baseline;&#xD;
Symptomatic gastroduodenal ulcer (confirmed by means of endoscopy or computed tomography) without evidence of gastrointestinal bleeding;&#xD;
Persistent pain of presumed gastrointestinal origin (duration ≥ 3 days) with underlying multiple erosive disease (5 or more gastroduodenal erosions confirmed by means of endoscopy);&#xD;
Obstruction; or&#xD;
Perforation.&#xD;
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The event rate of overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of overt upper GI bleeding of unknown origin</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of bleeding of presumed occult GI origin with the documented decrease in Hgb of≥2g/dL or decrease in hematocrit≥10% from baseline</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of symptomatic gastroduodenal ulcer(confirmed by means of endoscopy or computed tomography) without evidence of GI bleeding</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of the existence of persistent pain of presumed GI origin(duration ≥ 3 days) with underlying multiple erosive diseases (5 or more gastroduodenal erosions confirmed by means of endoscopy)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of gastrointestinal obstruction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of gastrointestinal perforation</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time from randomization to discontinuation of study medication attributed to gastrointestinal signs or symptoms</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically confirmed erosive esophagitis</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of composite cardiovascular safety endpoints</measure>
    <time_frame>12 months</time_frame>
    <description>composite cardiovascular safety endpoints including:&#xD;
death from cardiovascular causes;&#xD;
myocardial infarction; or&#xD;
stroke&#xD;
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of death from cardiovascular causes</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of stroke</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of any coronary or peripheral revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of all-cause mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>P-CAB 50mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tegoprazan 50 mg + rabeprazole 20mg placebo, once daily. Target enrollment: 1300</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPI group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rabeprazole 20mg + tegoprazan 50 mg placebo, once daily. Target enrollment: 1300</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PPI</intervention_name>
    <description>rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.</description>
    <arm_group_label>PPI group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P-CAB 50</intervention_name>
    <description>tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.</description>
    <arm_group_label>P-CAB 50mg group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 1. Patients 19 years of age or older with known cardiovascular disease in whom a&#xD;
             requirement for chronic use of antithrombotic therapy (either antiplatelets or OAC).&#xD;
             Specific clinical conditions that may confer a need for long-term antithrombotic&#xD;
             therapy may include acute coronary syndrome and those with a history of myocardial&#xD;
             infarction, stable or unstable angina, coronary or other arterial revascularization,&#xD;
             stroke, transient ischemic attack, peripheral arterial disease, or atrial&#xD;
             fibrillation. Concomitant use of a proton pump inhibitor is recommended in patients&#xD;
             receiving aspirin monotherapy, DAPT (dual antiplatelet therapy), DAT (dual&#xD;
             antithrombotic therapy), TAT (triple antithrombotic therapy.), or OAC monotherapy who&#xD;
             are at high risk of gastrointestinal bleeding in order to reduce the risk of gastric&#xD;
             bleeds.&#xD;
&#xD;
          2. On the basis of clinical guidelines and expert consensus documents, we defined study&#xD;
             population with increased risk of gastrointestinal bleeding if they had a least 1 or&#xD;
             more criteria of the following characteristics. Eligible patients for randomization&#xD;
             must meet at least 1 characteristic of these criteria:&#xD;
&#xD;
             *Definition of patients who are at high risk of gastrointestinal bleeding&#xD;
&#xD;
               1. Age ≥65 years&#xD;
&#xD;
               2. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or&#xD;
                  TAT)&#xD;
&#xD;
               3. Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids&#xD;
                  or high dose NSAID therapy even during a relatively short-term period.&#xD;
&#xD;
               4. History of prior GI bleeding events at any time&#xD;
&#xD;
               5. History of a previously complicated ulcer&#xD;
&#xD;
               6. History of peptic ulcer disease or a previously uncomplicated ulcer&#xD;
&#xD;
               7. Documented Helicobacter pylori infection&#xD;
&#xD;
          3. Patients who voluntarily participated in the written agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active bleeding at the time of inclusion or a history of hereditary or acquired&#xD;
             hemostatic disorder&#xD;
&#xD;
          2. Any clinical contraindication to using of antithrombotic therapies (antiplatelet&#xD;
             agents or OAC)&#xD;
&#xD;
          3. Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the&#xD;
             time of randomization, refractory ventricular arrhythmias, or congestive heart failure&#xD;
             (New York Heart Association class IV).&#xD;
&#xD;
          4. Baseline severe anemia (Hgb &lt;8 g/dl at baseline) or transfusion within 4 weeks before&#xD;
             randomization&#xD;
&#xD;
          5. Baseline severe thrombocytopenia (platelet count &lt;50,000/mm3)&#xD;
&#xD;
          6. Renal failure dependent on dialysis or severe renal insufficiency (creatinine&#xD;
             clearance &lt;15 ml/min)&#xD;
&#xD;
          7. Severe chronic liver disease (defined as variceal hemorrhage, ascites, hepatic&#xD;
             encephalopathy, or jaundice)&#xD;
&#xD;
          8. Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or&#xD;
             substituted benzimidazoles&#xD;
&#xD;
          9. Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter&#xD;
             pylori eradication&#xD;
&#xD;
         10. Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide&#xD;
             for Helicobacter pylori eradication&#xD;
&#xD;
         11. Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g.,&#xD;
             systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus&#xD;
             [HIV]-protease inhibitors, such as ritonavir)&#xD;
&#xD;
         12. Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see&#xD;
             Drug-Drug interaction section)&#xD;
&#xD;
         13. Clinically significant laboratory abnormality at screening (estimated glomerular&#xD;
             filtration rate (eGFR) &lt;15 mL/min or elevated liver enzyme [AST, ALT, ALP, total&#xD;
             bilirubin] &gt; 3 times upper normal limit [UNL] or any other condition that, in the&#xD;
             opinion of the Investigator, precludes participation in the study&#xD;
&#xD;
         14. Any known or suspected malignancy&#xD;
&#xD;
         15. Subjects with non-cardiac co-morbidities with a life expectancy of less than 12 months&#xD;
&#xD;
         16. Subjects with active treatment for H-pylori infection&#xD;
&#xD;
         17. Women who are pregnant or breastfeeding or female subjects, premenopausal who are not&#xD;
             surgically sterile, or, if sexually active not practicing an effective method of birth&#xD;
             control (e.g., prescription oral contraceptives, contraceptive injections,&#xD;
             intrauterine device, double-barrier method, contraceptive patch, male partner&#xD;
             sterilization) before entry and throughout the study; and, for those of childbearing&#xD;
             potential, who have a positive pregnancy test at screening&#xD;
&#xD;
         18. Participation in another clinical study within 12 months. However, where at least one&#xD;
             or more conditions are satisfied, it could be an exception according to an&#xD;
             investigator's discretion;&#xD;
&#xD;
               1. Participated in the observational study expected no effect on the safety and/or&#xD;
                  effectiveness evaluation of this trial&#xD;
&#xD;
               2. Screening failed before any interventional factor is involved&#xD;
&#xD;
               3. Participated in academic trials like strategic or medical device comparison&#xD;
                  studies conducted under standard therapy provided that there is no additional&#xD;
                  risk or a specific procedure to a subject and no interference between this trial&#xD;
                  and other studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jeong-youn Bae, RN</last_name>
    <phone>82230107259</phone>
    <email>cvcrc10@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duk-woo Park, MD</last_name>
      <email>dwpark@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Duk-woo Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Duk-Woo Park, MD</investigator_full_name>
    <investigator_title>Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine</investigator_title>
  </responsible_party>
  <keyword>gastroduodenal ulcer</keyword>
  <keyword>gastrointestinal hemorrhage</keyword>
  <keyword>peptic ulcer</keyword>
  <keyword>acute coronary syndrome</keyword>
  <keyword>coronary artery stent placement</keyword>
  <keyword>antiplatelet</keyword>
  <keyword>anticoagulant therapy</keyword>
  <keyword>PPI</keyword>
  <keyword>P-CAB</keyword>
  <keyword>Proton-pump inhibitors</keyword>
  <keyword>Potassium-Competitive Acid Blockers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04416581
org study id: AMCCV2020-05
nct id: NCT04416581
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to evaluate the efficacy and safety of P-CAB (tegoprazan 50
      mg once daily) as compared with PPI (rabeprazole 20 mg once daily) for protection of GI
      events in patients with cardiovascular disease receiving antiplatelet and oral anticoagulant
      therapy who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental
      arm) is non-inferior to PPI (standard arm) with respect to the rate of the primary composite
      endpoint of GI events at 6 months.
Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to
      perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure
      the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be
      included in the data set used for primary analyses.

      The safety of tegoprazan will be estimated SIAEs(Special Interest Adverse Events) as follows;
      Composite Event

        1. liver function abnormalities

        2. hypergastrinemia, or

        3. enteric infection

      Definitions

        -  liver function abnormality: defined as AST or ALT>3× upper limit of normal or two
           consecutive measurements of total bilirubin >2 x upper limit of normal

        -  hypergastrinemia

        -  enteric infection including C.difficile infection

      If there are any new tegoprazan-related findings, it will be considered in the estimation.

      If there is no safety concern during safety surveillance phase, investigator-driven,
      randomized, double-blind, double-dummy, active-controlled, clinical trial (N = 2,600
      patients) will be subsequently performed (randomization phase).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period (which was defined as the time from the first administration of a trial drug through 6 months of therapy)
time frame: 12 months
description: This composite outcome included:
Overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography);
Overt upper gastrointestinal bleeding of unknown origin;
Bleeding of presumed occult gastrointestinal origin with a documented decrease in haemoglobin of ≥ 2 g/dL or decrease in hematocrit ≥ 10% from baseline;
Symptomatic gastroduodenal ulcer (confirmed by means of endoscopy or computed tomography) without evidence of gastrointestinal bleeding;
Persistent pain of presumed gastrointestinal origin (duration ≥ 3 days) with underlying multiple erosive disease (5 or more gastroduodenal erosions confirmed by means of endoscopy);
Obstruction; or
Perforation.
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
measure: The event rate of overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography)
time frame: 12 months
measure: The event rate of overt upper GI bleeding of unknown origin
time frame: 12 months
measure: The event rate of bleeding of presumed occult GI origin with the documented decrease in Hgb of≥2g/dL or decrease in hematocrit≥10% from baseline
time frame: 12 months
measure: The event rate of symptomatic gastroduodenal ulcer(confirmed by means of endoscopy or computed tomography) without evidence of GI bleeding
time frame: 12 months
measure: The event rate of the existence of persistent pain of presumed GI origin(duration ≥ 3 days) with underlying multiple erosive diseases (5 or more gastroduodenal erosions confirmed by means of endoscopy)
time frame: 12 months
measure: The event rate of gastrointestinal obstruction
time frame: 12 months
measure: The event rate of gastrointestinal perforation
time frame: 12 months
measure: The time from randomization to discontinuation of study medication attributed to gastrointestinal signs or symptoms
time frame: 12 months
measure: The event rate of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically confirmed erosive esophagitis
time frame: 12 months
measure: The event rate of composite cardiovascular safety endpoints
time frame: 12 months
description: composite cardiovascular safety endpoints including:
death from cardiovascular causes;
myocardial infarction; or
stroke
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
measure: The event rate of death from cardiovascular causes
time frame: 12 months
measure: The event rate of myocardial infarction
time frame: 12 months
measure: The event rate of stroke
time frame: 12 months
measure: The event rate of any coronary or peripheral revascularization
time frame: 12 months
measure: The event rate of all-cause mortality
time frame: 12 months
arm group label: P-CAB 50mg group
arm group type: Experimental
description: tegoprazan 50 mg + rabeprazole 20mg placebo, once daily. Target enrollment: 1300
arm group label: PPI group
arm group type: Active Comparator
description: rabeprazole 20mg + tegoprazan 50 mg placebo, once daily. Target enrollment: 1300
intervention type: Drug
intervention name: PPI
description: rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
arm group label: PPI group
intervention type: Drug
intervention name: P-CAB 50
description: tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.
arm group label: P-CAB 50mg group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong-youn Bae, RN
phone: 82230107259
email: cvcrc10@amc.seoul.kr
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Duk-Woo Park, MD
investigator title: Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Infarction
sharing ipd: Undecided