EUCTR2018-000916-75-NL进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction - REC-DUT-002
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female born between 1933 and 2000.
- •2. Body weight <96 kg (~212 lb).
- •3. Able to provide written informed consent, including signing and
- •dating the informed consent form (ICF).
- •4. Diagnosis of STEMI (defined as new ST-segment elevation at the J
- •point of at least 2 continuous leads of >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 Thrombolysis
- •in Myocardial Infarction flow grade 2 or 3 occurring >2 hours and <24
- •hours after symptom onset.
- •5. LVEF =45% obtained by cECHO performed within 36 hours post-stent
- •6. Receiving standard medical therapy for post-myocardial infarction
- •(MI) treatment, according to local procedures and PI 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 effective contraception during the study.
- •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
排除标准
- •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
- •8. Treatment with any DPP4 inhibitors (e.g., alogliptin, linagliptin,
- •vildagliptin, saxagliptin, sitagliptin) or granulocyte-colony stimulating
- •factor 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 <9 g/dL prior to Randomization.
- •11. Thrombocytosis (platelets >500 k/uL).
- •12. Known positive serology for hepatitis B, hepatitis C, or human
- •immunodeficiency virus (HIV).
- •13. Alanine aminotransferase (ALT) concentrations >3 times the upper
- •limit of normal (ULN) or bilirubin >2 x ULN prior to Randomization,
- •according to local laboratory assessments.
- •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-MRI-compatible, cochlear implant, 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 prior 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 no 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
- 另有 11 项未显示
研究者
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