Acute myocardial infarction, acute myocardial ischemia, STEMI ST elevation myocardial infarction
Conditions
Interventions
Product Name: dutogliptin tartrate
Product Code: PHX1149T
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dutogliptin tartrate
CAS Number: 890402-81-0
Current Sponsor code: PHX1149T
C
Sponsors
RECARDIO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age 18 to 85 (having reached 18 and before having reached 86 at the time of ICF signing) 2. Body weight 2 mm [0.2 mV] in men or >1.5 mm [0.1 mV] in women in leads V2 and V3 OR >1 mm in any other contiguous precordial leads or the limb leads [for both men and women]) with PCI (bare metal or drug-eluting stent) and thrombolysisin myocardial infarction flow grade 2 or 3 occurring up to 24 hours after symptom onset (to time of first balloon inflation). 5. Left ventricular ejection fraction (LVEF) =45% obtained by cECHO performed within 36 hours post-stent placement. 6. Receiving standard medical therapy for post-MI treatment, according to local procedures and the Principal Investigator’s discretion. 7. Female subjects 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. 8. Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a bilateral oophorectomy, hysterectomy, or tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use highly effective contraception during treatment and for 4 weeks after the last dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Previous MI prior to Screening. 2. Complex peri/post-MI clinical course, including arrhythmias, cardiogenic shock, pulmonary edema requiring mechanical ventilation, or requirement for vasopressor medications. 3. Significant pre-existing cardiomyopathy with known LVEF =45% or moderate to severe mitral or aortic valvular disease. 4. Amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis. 5. Existing heart transplant. 6. Ventricular tachycardia or fibrillation not associated with an acute ischemic episode. 7. Uncontrolled hypertension (systolic >180 mmHg or diastolic >120 mmHg). 8. Treatment with any DPP4 inhibitors (e.g., alogliptin, linagliptin, vildagliptin, saxagliptin, sitagliptin) or G-CSF medication (e.g., filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to Randomization 9. Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication. 10. Anemia defined as hemoglobin 500 k/µL). 12. Known positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), any other indication of liver disease or injury 13. ALT concentrations >3 times the upper limit of normal (ULN) and bilirubin (TBL) >2 x ULN, or INR >1.5 prior to Randomization, according to local laboratory assessments, and/or any indication of liver disease or injury. If ALT is between >3 and 8 x ULN, and all other admission criteria are met, the test may be repeated within the time window before Randomization. 14. History of cirrhosis and Child-Pugh score B or C 15. Current fever greater than 101.4 °F (38.6 °C) or recent systemic infection within 2 weeks prior to Randomization. 16. Contraindication to cMRI procedure, including prior implantable cardioverter defibrillator placement, known reaction to gadolinium, claustrophobia, non-MRIcompatible, cochlear implant, morbid obesity, or presence of ferromagnetic material including shunts, shrapnel, penile prostheses, or blood vessel coil. 17. Pregnant, planning to become pregnant, or nursing female subjects. 18. Autoimmune disease requiring immunosuppressive therapy or chronic steroid treatment >5 mg/day prednisolone or equivalent. 19. Significant renal impairment defined as estimated glomerular filtration rate <45 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration equation. 20. Active neoplasm requiring surgery, chemotherapy, or radiation within the past 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to Screening with any detectable recurrence are allowed). 21. Malignant hematological disease, i.e., chronic myeloid leukemia or myelodysplastic syndrome. 22. History of cerebrovascular accident or transient ischemic attack in the past 6 months. 23. History of pneumonia in the last 4 weeks. 24. History of any significant medical or psychiatric disorder that in the opinion of the Investigator would make the subject unsuitable for participation in the study. 25. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) or treatment with an investigational biologic drug within 6 weeks prior to randomization. 26. Participation in another concurrent clinical trial involving a therapeutic intervention (participation in observational studies and/or registry stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo;Secondary Objective: • To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo • To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population • To establish the pharmacodynamics (PD) of dutogliptin (plasma dipeptidyl peptidase-IV DPP4 activity) in a subset of the study population • To evaluate the change from baseline in plasma biomarkers N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin ;Primary end point(s): Safety assessments will include reporting of AEs and serious AEs (SAEs), clinical laboratory tests, ECGs, vital signs, and physical examinations.;Timepoint(s) of evaluation of this end point: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 90 days;Secondary end point(s): Efficacy 1 Change from baseline to Day 90 (Month 3) in the following cardiac functional parameters as assessed by central, blinded review of cMRI: - Left ventricular ejection fraction (LVEF) - Left ventricular end systolic volume (absolute and indexed) - Left ventricular end diastolic volume (absolute and indexed) - Infarct size - Left ventricular mass (absolute and indexed) - Regional wall motion Efficacy 2 Individual clinical endpoints, including recurrent non-fatal MI, non-fatal stroke, death due to any cause, cardiovascular (CV) death (death due to acute MI, chronic heart failure [CHF], stroke, or sudden cardiac death), stent thrombosis or CHF hospitalization. Efficacy 3 Combined clinical endpoints, including major adverse cardiac events, defined as non-fatal MI, non-fatal stroke, CV death, stent thrombosis, and CHF hospitalization Efficacy 4 Time to cardiovascular event, as defined by the time from Randomization to the first occurrence of recurrent non-fatal MI, non-fatal stroke, death due to any cause, stent thrombosis, and CHF hospitalization | — |
Countries
Austria, Belgium, Bulgaria, Hungary, Netherlands, Poland, United States
Contacts
Public ContactCEO
Recardio Inc
Outcome results
None listed