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Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction (HEAL-MI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dutogliptin + Filgrastim
Placebo
Sponsored by
Recardio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, age 18 to 85 years (having reached 18 years of age and before having reached 86 years of age at the time of ICF signing) Able to provide written informed consent, including signing and dating the ICF STEMI is defined as follows: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) AND Anterior STEMI: ECG Criteria men > 40 years: ≥ 2 mm of new ST elevation in V2 and V3 men ≤ 40 years: ≥ 2.5 mm of new ST elevation in V2 and V3 women: ≥ 1.5 mm of new ST elevation in V2 and V3 ECG Criteria o ≥ 1 mm of new ST elevation in two contiguous leads 4. STEMI must meet one of the following criteria: Anterior STEMI with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow at presentation Non-anterior MI with the following: TIMI 0 flow at presentation AND Signs of HF, defined as at least one of the following radiographic evidence of pulmonary congestion, peripheral edema, increased jugular venous pressure, hepatojugular reflux or both, third heart sound or gallop 6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation. Exclusion Criteria: Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease Known pre-existing left ventricular ejection fraction < 40% Existing heart transplant Treatment with any dipeptidyl peptidase 4 (DPP4) inhibitors (eg, alogliptin, lingliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte colony-stimulation factor (G-CSF) medication (eg, filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to randomization. Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication Pregnant, planning to become pregnant, or nursing female patients Known history of severe renal impairment or current renal impairment requiring dialysis History of pancreatitis (induced by high doses of DPP-4 inhibitors) Current or planned use of sulfonyl urea (risk of severe hypoglycemia) Any clinically significant abnormality identified prior to randomization that in the judgement of the Investigator or Sponsor that would preclude safe completion of the study, or confound the anticipated benefit of dutogliptin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dutogliptin + Filgrastim

    Placebo-Dutogliptin + Placebo-Filgrastim

    Arm Description

    Participants will receive BID SC injections of 60 mg dutogliptin for 14 days in co-administration with 10 µg/kg filgrastim for 5 days.

    Randomized participants will receive BID SC injections of dutogliptin placebo for 14 days in co-administration with filgrastim placebo for 5 days.

    Outcomes

    Primary Outcome Measures

    Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
    defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure

    Secondary Outcome Measures

    Time to cardiovascular death
    defined as the time from randomization to the date of cardiovascular death
    Worsening heart failure
    defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
    Total symptom score of the Kansas City Cardiomyopathy Questionnaire

    Full Information

    First Posted
    May 19, 2023
    Last Updated
    June 1, 2023
    Sponsor
    Recardio, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05881382
    Brief Title
    Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
    Acronym
    HEAL-MI
    Official Title
    Phase 3, Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Recardio, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST Elevation Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    4100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dutogliptin + Filgrastim
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive BID SC injections of 60 mg dutogliptin for 14 days in co-administration with 10 µg/kg filgrastim for 5 days.
    Arm Title
    Placebo-Dutogliptin + Placebo-Filgrastim
    Arm Type
    Placebo Comparator
    Arm Description
    Randomized participants will receive BID SC injections of dutogliptin placebo for 14 days in co-administration with filgrastim placebo for 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Dutogliptin + Filgrastim
    Intervention Description
    dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.
    Primary Outcome Measure Information:
    Title
    Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
    Description
    defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
    Time Frame
    within 180 days of randomization
    Secondary Outcome Measure Information:
    Title
    Time to cardiovascular death
    Description
    defined as the time from randomization to the date of cardiovascular death
    Time Frame
    within 180 days of randomization
    Title
    Worsening heart failure
    Description
    defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
    Time Frame
    within 180 days of randomization
    Title
    Total symptom score of the Kansas City Cardiomyopathy Questionnaire
    Time Frame
    at 180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, age 18 to 85 years (having reached 18 years of age and before having reached 86 years of age at the time of ICF signing) Able to provide written informed consent, including signing and dating the ICF STEMI is defined as follows: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) AND Anterior STEMI: ECG Criteria men > 40 years: ≥ 2 mm of new ST elevation in V2 and V3 men ≤ 40 years: ≥ 2.5 mm of new ST elevation in V2 and V3 women: ≥ 1.5 mm of new ST elevation in V2 and V3 ECG Criteria o ≥ 1 mm of new ST elevation in two contiguous leads 4. STEMI must meet one of the following criteria: Anterior STEMI with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow at presentation Non-anterior MI with the following: TIMI 0 flow at presentation AND Signs of HF, defined as at least one of the following radiographic evidence of pulmonary congestion, peripheral edema, increased jugular venous pressure, hepatojugular reflux or both, third heart sound or gallop 6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation. Exclusion Criteria: Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease Known pre-existing left ventricular ejection fraction < 40% Existing heart transplant Treatment with any dipeptidyl peptidase 4 (DPP4) inhibitors (eg, alogliptin, lingliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte colony-stimulation factor (G-CSF) medication (eg, filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to randomization. Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication Pregnant, planning to become pregnant, or nursing female patients Known history of severe renal impairment or current renal impairment requiring dialysis History of pancreatitis (induced by high doses of DPP-4 inhibitors) Current or planned use of sulfonyl urea (risk of severe hypoglycemia) Any clinically significant abnormality identified prior to randomization that in the judgement of the Investigator or Sponsor that would preclude safe completion of the study, or confound the anticipated benefit of dutogliptin

    12. IPD Sharing Statement

    Learn more about this trial

    Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction

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