Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction (HEAL-MI)
ST Elevation Myocardial Infarction
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Dutogliptin + Filgrastim
Placebo-Dutogliptin + Placebo-Filgrastim
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.