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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04463251
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
Cromos Pharma, LLC
DM 365, LLC
Keystat, LLC
Information provided by (Responsible Party):
R-Pharm ( R-Pharm Overseas, Inc. )

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Acute ST Segment Elevation Myocardial Infarction Biological: RPH-104 80 mg Drug: Placebo Phase 2

Detailed Description:

146 male and female subjects aged from 18 years old (inclusive) hospitalized with STEMI will be enrolled in the study. 102 subjects will be randomized, 34 subjects per group.

After signing informed consent, the investigator will assess the subject's eligibility for the study. The screening will be made on Day 1 of the study.

Subjects will be randomly assigned to 1 of 3 treatment groups (in a 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.

Follow-up period after administration of the study products will last for 4 weeks and will include follow-up after administration of the study product (Day 1), Visit 2 (Day 3), Visit 3 (Day 14) and Visit 4 (Day 28±1). The following will be performed during this period: the subject's condition monitoring, laboratory and instrumental examination.

Additional clinical follow-up will last for 12 months after the study product administration and will include Visit 5 (Month 6 ±2 weeks) and Visit 6 (Month 12 ±2 weeks). During this period, the subject's condition will be monitored and laboratory and instrumental examination 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 study is planned to be conducted in Russian Federation and USA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : May 14, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: RPH-104 80 mg
subjects will receive subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites
Biological: RPH-104 80 mg
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial

Drug: Placebo
Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial

Experimental: RPH-104 160 mg
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
Biological: RPH-104 80 mg
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial

Placebo Comparator: Placebo
subjects will receive subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
Drug: Placebo
Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial




Primary Outcome Measures :
  1. hsCRP area under curve (AUC) from baseline until Day 14 [ Time Frame: Day 1 , Day 3 and Day 14 ]
    hsCRP area under curve (AUC) from baseline (Day 1) until Day 14


Secondary Outcome Measures :
  1. hsCRP area under curve (AUC) from baseline until Day 28 [ Time Frame: From Day 1 until Day 28 ]
    hsCRP area under curve (AUC) from baseline (Day 1) until Day 28

  2. Rate of fatal outcomes (cardiac and non-cardiac), hospitalizations (due to heart failure (HF) and other cardiac reasons not associated with HF or due to non-cardiac reasons) during 12-month follow-up period [ Time Frame: From Day 1 until Day 365 ]
    Rate of fatal outcomes (cardiac and non-cardiac), hospitalizations (due to heart failure (HF) and other cardiac reasons not associated with HF or due to non-cardiac reasons) during 12-month follow-up period

  3. Frequency of new cases of HF during 12-month follow-up period [ Time Frame: From Day 1 until Day 365 ]
    Frequency of new cases of HF (defined as hospitalization due to HF or necessity in a loop diuretic administration intravenously or oral dose doubling in the relevant clinical facilities) during 12-month follow-up period

  4. 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 ]
    Changes in levels of brain natriuretic peptide (BNP, NT-proBNP) during 12-month follow-up period compared to baseline

  5. Changes in structural and functional echocardiographic parameters : left ventricular (LV) and right ventricular dimensions after 12 months compared to baseline [ Time Frame: From Day 1 Until Day 365 ]
    Changes in structural and functional echocardiographic parameters : left ventricular (LV) and right ventricular dimensions after 12 months compared to baseline

  6. Changes in structural and functional echocardiographic parameters : Left ventricular muscle mass index (LVMMI) after 12 months compared to baseline [ Time Frame: From Day 1 Until Day 365 ]
    Changes in structural and functional echocardiographic parameters : Left ventricular muscle mass index (LVMMI) after 12 months compared to baseline

  7. Changes in structural and functional echocardiographic parameters : LV systolic function after 12 months compared to baseline [ Time Frame: From Day 1 Until Day 365 ]
    Changes in structural and functional echocardiographic parameters :LV systolic function after 12 months compared to baseline

  8. Changes in structural and functional echocardiographic parameters : LV diastolic function after 12 months compared to baseline [ Time Frame: From Day 1 Until Day 365 ]
    Changes in structural and functional echocardiographic parameters :LV diastolic function after 12 months compared to baseline



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who gave voluntary written Informed consent to participate in the study and to follow all Protocol procedures.
  • STEMI diagnosis defined as chest pain or its equivalent with debut no more than 12 hours before randomization and ECG findings evidencing ST elevation (>1 mm) in two or more consecutive leads or acute left bunch branch block (LBBB) according the investigator's judgement.
  • Percutaneous coronary intervention (PCI) with stenting was performed within no more than 12 hours after onset of chest pain or its equivalent before randomization.
  • Consent of female subjects with childbearing potential defined as all female subjects with physiological potential to conceive, to use highly effective contraceptive methods throughout the study starting from screening (signing Informed Consent Form) and negative pregnancy test.

Highly effective contraceptive methods include combination of two of the following methods (a+b or a+c or b+c):

  1. oral, injection or implanted hormonal contraceptives; in case of oral contraceptives, the female subjects should administer the same product for at least 3 months prior to the study therapy;
  2. intrauterine device or contraceptive system;
  3. barrier methods: condom or occlusive cap (diaphragm or cervical cap / vaginal fornix cap) with spermicidal foam/gel/film/cream/vaginal suppository

    • Ability and willingness of the subject, according to the reasonable investigator's judgment, to attend the study site at all scheduled visits, undergo the study procedures and follow the protocol requirements including subcutaneous injections by qualified site personnel.

Exclusion Criteria:

  • Hypersensitivity to test product (RPH-104) and/or its ingredients/excipients.
  • Pregnancy and breastfeeding.
  • Verified chronic heart failure (The American Heart Association / The American College of Cardiology (AHA/ACC) A-D class, New York Heart Association (NYHA) Functional class (FC) I-IV)
  • Pre-existing decompensated heart defects.
  • History of STEMI
  • Complications of acute myocardial infarction in the form of acute left ventricular failure and cardiogenic shock defined as stable blood pressure decrease (SBP<90 mm Hg) associated with signs of hypoperfusion as well as cases when inotropic and/or mechanical support is required to maintain SBP; and / or unstable hemodynamics.
  • Active infections (acute or chronic); active tuberculosis
  • Recent (less than 5 half-life periods) or current administration of agents with an immunosuppressant mechanism of action, including, but not limited to, high doses of glucocorticoids (> 1 mg/kg of methylprednisolone equivalent),Tumour Necrosis Factor (TNF) alpha blockers, Interleukin-1 (IL-1) and other biological drugs, cyclosporine and other immunosuppressants. NSAIDs are allowed.
  • Immunization with live vaccines within 90 days prior to the study product administration.
  • Chronic systemic autoimmune or autoinflammatory diseases
  • Suspected necessity in cardiosurgery
  • Oncology (or diagnosis of oncology within the last 5 years).
  • History of organ transplantation or necessity in transplantation at the screening initiation or scheduled transplantation during the study.
  • Neutropenia (absolute neutrophil count <1800/mm3).
  • Participation in another clinical study within the previous 3 months prior to Screening visit.
  • Other medical or mental conditions or abnormal laboratory findings which may increase the risk for the subject associated with the study participation or administration of the study products or which may affect interpretation of the study results and, according to the investigator, render the subject ineligible for the study.
  • The subjects working at the study site or subjects working for Sponsor directly involved in this clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463251


Locations
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Russian Federation
Regional State budgetary healthcare institution " Altai regional cardiological dispensary"
Barnaul, Russian Federation, 656055
Contact: Alexey I. Duda    +7 913 270 81 08    alexeyduda@mail.ru   
State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital №64" of the Moscow Department of Health
Moscow, Russian Federation, 117292
Contact: Imad A. Meray    +7 916 182 22 30    imadmerai@yahoo.com   
State Institution of Healthcare in Moscow "City Clinical Hospital № 51 Moscow Health Department"
Moscow, Russian Federation, 121309
Contact: Dmitry V. Privalov    +7 926 214 64 04    d.v.priv@mail.ru   
Federal State Institution "Russian Cardiology Research and Production Complex" of the Ministry of Healthcare of the Russian Federation
Moscow, Russian Federation, 121552
Contact: Dmitry V. Pevzner    +7 916 696 32 92    pevsner@mail.ru   
State Budgetary Institution of Healthcare "City Clinical Hospital #52", Moscow City Healthcare Department
Moscow, Russian Federation, 123182
Contact: Georgy N. Abrolishvili    +7 926 529 71 33    geodoc@yandex.ru   
Moscow State Clinical Hospital named after V.V. Veresaev
Moscow, Russian Federation, 127644
Contact: Shogenov S. Zaur    +7 985 769 28 96    zaurshogenov@yandex.ru   
State Autonomous institution of healthcare of the Perm region "City clinical hospital № 4"
Perm, Russian Federation, 2614107
Contact: Oleg M. Lapin    +7 902 471 36 59    heparin@yandex.ru   
State budgetary educational institution of higher professional education "North-Western State Medical University named after I.I. Mechnikov"
Saint Petersburg, Russian Federation, 191015
Contact: Svetlana A. Boldueva    +7 921 931 74 49    svetlanaboldueva@mail.ru   
State Budgetary Institution of Healthcare of Saint-Petersburg "Hospital for war veterans"
Saint Petersburg, Russian Federation, 193079
Contact: Vladimir O. Konstantinov    +7 921 948 72 31    atherosclerosis@mail.ru   
National medical research center named after V. A. Almazov
Saint Petersburg, Russian Federation, 197341
Contact: Alexei N. Yakovlev    +7 905 251 64 65    alex.yakovlev@mail.ru   
Saint-Petersburg State Budgetary Institution of Healthcare "City Hospital №40"
Saint Petersburg, Russian Federation, 197706
Contact: Alina S. Agafyina    +7 921 58378 08    a.agafina@mail.ru   
State budgetary educational institution of higher professional education "North-Western State Medical University named after I.I. Mechnikov", Pokrovskaya Hospital
Saint Petersburg, Russian Federation, 199106
Contact: Sergey A. Sayganov    +7 921 948 40 93    sergey.sayganov@mail.ru   
Sponsors and Collaborators
R-Pharm Overseas, Inc.
Cromos Pharma, LLC
DM 365, LLC
Keystat, LLC
Investigators
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Study Director: Yan Lavrovsky R-Pharm Overseas, Inc.
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Responsible Party: R-Pharm Overseas, Inc.
ClinicalTrials.gov Identifier: NCT04463251    
Other Study ID Numbers: CL04018075
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by R-Pharm ( R-Pharm Overseas, Inc. ):
STEMI
Myocardial infarction
Cardiovascular diseases
CVD
Coronary heart disease
CHD
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Myocardial Infarction
ST Elevation Myocardial Infarction
Inflammation
Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia