<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/NCT04463251</url>
  </required_header>
  <id_info>
    <org_study_id>CL04018075</org_study_id>
    <nct_id>NCT04463251</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction</brief_title>
  <official_title>International, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R-Pharm Overseas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cromos Pharma LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Data Management 365</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keystat, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>R-Pharm</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>K-Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>R-Pharm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to evaluate the effect of single administration of RPH-104 at 80 mg&#xD;
      and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects&#xD;
      with ST-segment elevation myocardial infarction (STEMI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing informed consent, the investigator will assess the subject's eligibility for&#xD;
      the study. After signing the informed consent form, the investigator will assess the&#xD;
      subject's eligibility for the study. The following procedures will be performed during the&#xD;
      screening: collection of medical history, recording previous and concomitant therapy,&#xD;
      demographic data, recording 12-lead ECG findings on which STEMI diagnosis was based,&#xD;
      recording date and time of STEMI symptom development, recording date, time and results of&#xD;
      coronary angiography (CAG) at admission to the study site, measurement of blood neutrophil&#xD;
      count, vital signs, physical examination including measurement of body weight (if hospital&#xD;
      bed is available), blood sampling for hematology, biochemistry, determination of&#xD;
      concentration of hsCRP and brain natriuretic peptide (BNP; N-terminal (NT)-pro hormone brain&#xD;
      natriuretic peptide (NT-pro-BNP)), for females with retained reproductive potential -&#xD;
      pregnancy test (test strips).&#xD;
&#xD;
      The subjects meeting selection criteria will be randomized to one of the three groups (in&#xD;
      1:1:1 ratio) for single subcutaneous administration of RPH-104 80 mg, RPH-104 160 mg or&#xD;
      placebo.&#xD;
&#xD;
      Screening, randomization and administration of the study products will be made on the same&#xD;
      (first) study day.&#xD;
&#xD;
      Further 4-week (28-day) clinical follow-up and additional 6- and 12-month clinical follow-up&#xD;
      period will be performed.&#xD;
&#xD;
      The end of clinical part of the study will be the date of the last visit of the last subject&#xD;
      within additional 12-month clinical follow-up.&#xD;
&#xD;
      The maximum number of screened patients will be 146 subjects, 102 subjects will be&#xD;
      randomized, 34 subjects per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Actual">October 10, 2022</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High-sensitive С-reactive protein (hsCRP) area under curve (AUC) from baseline until Day 14</measure>
    <time_frame>Day 1 until Day 14</time_frame>
    <description>hsCRP area under curve (AUC) from baseline (Day 1) until Day 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hsCRP AUC from baseline until Day 28</measure>
    <time_frame>up to Day 28</time_frame>
    <description>hsCRP AUC from baseline (Day 1) until Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fatal outcomes (cardiac and non-cardiac) during 12-month follow-up period</measure>
    <time_frame>up to Day 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hospitalizations due to heart failure (HF) or other cardiac reasons not associated with HF, or due to non-cardiac reasons during 12-month follow-up period</measure>
    <time_frame>up to Day 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of new cases of HF during 12-month follow-up period</measure>
    <time_frame>up to Day 365</time_frame>
    <description>New cases of HF are defined as hospitalization due to HF or new onset of HF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in levels of brain natriuretic peptide (BNP, NT-proBNP) during 12-month follow-up period compared to baseline</measure>
    <time_frame>From Day 1 until Day 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in End-diastolic (EDV) volume after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by echocardiography (Echo-CG) (in mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in End-systolic (ESV) volume after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in EF (Simpson BP) after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in percentage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in regional LV function after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Assessment of regional LV function using the wall motion score index (WMSI), measured by Echo-CG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fractional area change (FAC) parameter after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in percentage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE) parameter after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Transmitral flow rate</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Changes in Transmitral flow rate after 12 months compared to baseline, measured by Echo-CG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mitral valve (MV) septal e' velocity (e'sept) after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in cm/s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MV lateral e' velocity (e'lat) after 12 months compared to baseline</measure>
    <time_frame>From Day 1 Until Day 365</time_frame>
    <description>Measured by Echo-CG (in cm/s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BNP AUC from Day 1 (baseline) until Day 28</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-pro-BNP AUC from Day 1 (baseline) until Day 28</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of &quot;fatal outcome (due to any reason) or hospitalization due to HF or new onset of HF&quot; during 12-month follow-up period</measure>
    <time_frame>up to Day 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of &quot;fatal outcome (due to any reason) or hospitalization due to HF&quot; during 12-month follow-up period</measure>
    <time_frame>up to Day 365</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Acute ST Segment Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>RPH-104 80 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will receive subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RPH-104 160 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will receive subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects will receive subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RPH-104 80 mg</intervention_name>
    <description>solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial</description>
    <arm_group_label>RPH-104 160 mg</arm_group_label>
    <arm_group_label>RPH-104 80 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>RPH-104 80 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who gave voluntary written Informed consent to participate in the study and&#xD;
             to follow all Protocol procedures.&#xD;
&#xD;
          -  STEMI diagnosis defined as chest pain or its equivalent with ECG findings evidencing&#xD;
             ST elevation (&gt;1 mm) in two or more consecutive leads or acute left bunch branch block&#xD;
             according the investigator's judgement.&#xD;
&#xD;
          -  Percutaneous coronary intervention (PCI) with stenting was performed within no more&#xD;
             than 12 hours after onset of chest pain or its equivalent and randomization was&#xD;
             performed in no more than 12 hours after PCI (overall within 24 hours of onset of&#xD;
             chest pain or equivalent).&#xD;
&#xD;
          -  Consent of female subjects with childbearing potential defined as all female subjects&#xD;
             with physiological potential to conceive, to use highly effective contraceptive&#xD;
             methods throughout the study starting from screening (signing Informed Consent Form)&#xD;
             and negative pregnancy test.&#xD;
&#xD;
        Highly effective contraceptive methods include combination of two of the following methods&#xD;
        (a+b or a+c or b+c):&#xD;
&#xD;
          1. oral, injection or implanted hormonal contraceptives; in case of oral contraceptives,&#xD;
             the female subjects should administer the same product for at least 3 months prior to&#xD;
             the study therapy;&#xD;
&#xD;
          2. intrauterine device or contraceptive system;&#xD;
&#xD;
          3. barrier methods: condom or occlusive cap (diaphragm or cervical cap / vaginal fornix&#xD;
             cap) with spermicidal foam/gel/film/cream/vaginal suppository&#xD;
&#xD;
               -  Ability and willingness of the subject, according to the reasonable&#xD;
                  investigator's judgment, to attend the study site at all scheduled visits,&#xD;
                  undergo the study procedures and follow the Protocol requirements including&#xD;
                  subcutaneous injections by qualified site personnel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to test product (RPH-104) and/or its ingredients/excipients.&#xD;
&#xD;
          -  Pregnancy and breastfeeding.&#xD;
&#xD;
          -  Verified chronic heart failure (The American Heart Association / The American College&#xD;
             of Cardiology (AHA/ACC) C-D class, New York Heart Association (NYHA) Functional class&#xD;
             (FC) III-IV)&#xD;
&#xD;
          -  Pre-existing severe valvular heart disease according to the investigator's assessment.&#xD;
&#xD;
          -  Pre-existing left ventricular (LV) dysfunction (ejection fraction (EF)&lt;40%)&#xD;
&#xD;
          -  History of STEMI&#xD;
&#xD;
          -  Complications of acute myocardial infarction (MI) in the form of acute left&#xD;
             ventricular failure and cardiogenic shock defined as stable blood pressure decrease&#xD;
             (SBP&lt;90 mm Hg) associated with signs of hypoperfusion as well as cases when inotropic&#xD;
             and/or mechanical support is required to maintain SBP; and / or unstable hemodynamics.&#xD;
&#xD;
          -  Active infections (acute or chronic); active tuberculosis.&#xD;
&#xD;
          -  Recent (less than 5 half-life periods) or current administration of colchicine, as&#xD;
             well as agents with an immunosuppressant mechanism of action, including, but not&#xD;
             limited to:&#xD;
&#xD;
        glucocorticoids at doses of &gt; 1 mg/kg of methylprednisolone equivalent, tumor necrosis&#xD;
        factor-alfa (TNFα) blockers, Interleukin-1 (IL-1) and other biological drugs, cyclosporine&#xD;
        and other immunosuppressants. Non-steroidal anti-inflammatory drugs (NSAIDs) are allowed.&#xD;
&#xD;
          -  Immunization with live vaccines within 90 days prior to the study product&#xD;
             administration.&#xD;
&#xD;
          -  Chronic systemic autoimmune or autoinflammatory diseases&#xD;
&#xD;
          -  Suspected necessity in cardiosurgery.&#xD;
&#xD;
          -  Oncology (or diagnosis of oncology within the last 5 years).&#xD;
&#xD;
          -  History of organ transplantation or necessity in transplantation at the screening&#xD;
             initiation or scheduled transplantation during the study.&#xD;
&#xD;
          -  Neutropenia (absolute neutrophil count &lt;1800/mm^3).&#xD;
&#xD;
          -  Participation in another clinical study within the previous 3 months prior to&#xD;
             Screening visit.&#xD;
&#xD;
          -  Other medical (including mental) conditions or abnormal laboratory findings which may&#xD;
             increase the risk for the subject associated with the study participation or&#xD;
             administration of the study products or which may affect interpretation of the study&#xD;
             results and, according to the investigator, render the subject ineligible for the&#xD;
             study.*&#xD;
&#xD;
             *If, in the Investigator's opinion, administration of a non-live COVID-19 (SARS-CoV-2)&#xD;
             vaccine increases the risk for the patient related to his/her participation in the&#xD;
             study, the Investigator can make a decision not to include this patient into the&#xD;
             study.&#xD;
&#xD;
          -  The subjects working at the study site or subjects working for Sponsor directly&#xD;
             involved in this clinical study.&#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>Yan Lavrovsky</last_name>
    <role>Study Director</role>
    <affiliation>R-Pharm Overseas, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sinai Center of Thrombosis Research and Drug Development</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298-5051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare of Moscow &quot;City Clinical Hospital №64&quot; of the Moscow Department of Health</name>
      <address>
        <city>Moscow</city>
        <zip>117292</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution of Healthcare in Moscow &quot;City Clinical Hospital № 51 Moscow Health Department&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>121309</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Institution &quot;Russian Cardiology Research and Production Complex&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>121552</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow State Clinical Hospital named after V.V. Veresaev</name>
      <address>
        <city>Moscow</city>
        <zip>127644</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Autonomous institution of healthcare of the Perm region &quot;City clinical hospital № 4&quot;</name>
      <address>
        <city>Perm</city>
        <zip>2614107</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan State Medical University n.a. academician I.P. Pavlov on the basis of Regional Clinical cardiology Dispensary</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Budgetary Healthcare Institution &quot;Saint Martyr Elizabeth City Hospital&quot;</name>
      <address>
        <city>St Petersburg</city>
        <zip>195257</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The State Budgetary Health Care Institution of the Yaroslavl Region &quot;Regional Clinical Hospital&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>Myocardial infarction</keyword>
  <keyword>Cardiovascular diseases</keyword>
  <keyword>CVD</keyword>
  <keyword>Coronary heart disease</keyword>
  <keyword>CHD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_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/NCT04463251
org study id: CL04018075
nct id: NCT04463251
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of the study is to evaluate the effect of single administration of RPH-104 at 80 mg
      and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects
      with ST-segment elevation myocardial infarction (STEMI)
After signing informed consent, the investigator will assess the subject's eligibility for
      the study. After signing the informed consent form, the investigator will assess the
      subject's eligibility for the study. The following procedures will be performed during the
      screening: collection of medical history, recording previous and concomitant therapy,
      demographic data, recording 12-lead ECG findings on which STEMI diagnosis was based,
      recording date and time of STEMI symptom development, recording date, time and results of
      coronary angiography (CAG) at admission to the study site, measurement of blood neutrophil
      count, vital signs, physical examination including measurement of body weight (if hospital
      bed is available), blood sampling for hematology, biochemistry, determination of
      concentration of hsCRP and brain natriuretic peptide (BNP; N-terminal (NT)-pro hormone brain
      natriuretic peptide (NT-pro-BNP)), for females with retained reproductive potential -
      pregnancy test (test strips).

      The subjects meeting selection criteria will be randomized to one of the three groups (in
      1:1:1 ratio) for single subcutaneous administration of RPH-104 80 mg, RPH-104 160 mg or
      placebo.

      Screening, randomization and administration of the study products will be made on the same
      (first) study day.

      Further 4-week (28-day) clinical follow-up and additional 6- and 12-month clinical follow-up
      period will be performed.

      The end of clinical part of the study will be the date of the last visit of the last subject
      within additional 12-month clinical follow-up.

      The maximum number of screened patients will be 146 subjects, 102 subjects will be
      randomized, 34 subjects per group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: High-sensitive С-reactive protein (hsCRP) area under curve (AUC) from baseline until Day 14
time frame: Day 1 until Day 14
description: hsCRP area under curve (AUC) from baseline (Day 1) until Day 14
measure: hsCRP AUC from baseline until Day 28
time frame: up to Day 28
description: hsCRP AUC from baseline (Day 1) until Day 28
measure: Incidence of fatal outcomes (cardiac and non-cardiac) during 12-month follow-up period
time frame: up to Day 365
measure: Incidence of hospitalizations due to heart failure (HF) or other cardiac reasons not associated with HF, or due to non-cardiac reasons during 12-month follow-up period
time frame: up to Day 365
measure: Incidence of new cases of HF during 12-month follow-up period
time frame: up to Day 365
description: New cases of HF are defined as hospitalization due to HF or new onset of HF.
measure: Changes in levels of brain natriuretic peptide (BNP, NT-proBNP) during 12-month follow-up period compared to baseline
time frame: From Day 1 until Day 365
measure: Changes in End-diastolic (EDV) volume after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by echocardiography (Echo-CG) (in mL).
measure: Changes in End-systolic (ESV) volume after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in mL).
measure: Changes in EF (Simpson BP) after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in percentage).
measure: Changes in regional LV function after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Assessment of regional LV function using the wall motion score index (WMSI), measured by Echo-CG.
measure: Changes in fractional area change (FAC) parameter after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in percentage).
measure: Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE) parameter after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in mm).
measure: Changes in Transmitral flow rate
time frame: From Day 1 Until Day 365
description: Changes in Transmitral flow rate after 12 months compared to baseline, measured by Echo-CG.
measure: Changes in mitral valve (MV) septal e' velocity (e'sept) after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in cm/s).
measure: Changes in MV lateral e' velocity (e'lat) after 12 months compared to baseline
time frame: From Day 1 Until Day 365
description: Measured by Echo-CG (in cm/s).
measure: BNP AUC from Day 1 (baseline) until Day 28
time frame: up to Day 28
measure: NT-pro-BNP AUC from Day 1 (baseline) until Day 28
time frame: up to Day 28
measure: Incidence of "fatal outcome (due to any reason) or hospitalization due to HF or new onset of HF" during 12-month follow-up period
time frame: up to Day 365
measure: Incidence of "fatal outcome (due to any reason) or hospitalization due to HF" during 12-month follow-up period
time frame: up to Day 365
arm group label: RPH-104 80 mg
arm group type: Experimental
description: subjects will receive subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites
arm group label: RPH-104 160 mg
arm group type: Experimental
description: subjects will receive subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites
arm group label: Placebo
arm group type: Placebo Comparator
description: subjects will receive subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
intervention type: Biological
intervention name: RPH-104 80 mg
description: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
arm group label: RPH-104 160 mg
arm group label: RPH-104 80 mg
intervention type: Drug
intervention name: Placebo
description: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial
arm group label: Placebo
arm group label: RPH-104 80 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yan Lavrovsky
role: Study Director
affiliation: R-Pharm Overseas, Inc.
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country: Russian Federation
country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Inflammation
mesh term: Infarction