Patients undergoing routine percutaneous coronary revascularisation for acute ST segment elevation myocardial infarction (STEMI, time from onset of infarction to intervention 2 to 24 hours)
Conditions
Interventions
Trade Name: Januvia
Product Name: Januvia
Pharmaceutical Form: Tablet
INN or Proposed INN: Sitagliptin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmace
Sponsors
Vorstand des Klinikums der Universität München - Grosshadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old, male or female 2. Have acute ST segment elevation myocardial infarction (typical chest pain of more than 30 minutes duration, presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block) 3. Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI. 4. Patients who are suitable for coronary angiography and angioplasty with stenting of the infarct related artery. 5. PCI with stenting within 2-24 hours after onset of STEMI. 6. Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments. 7. Give a written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General: 1. Women of childbearing potential, pregnancy or being lactating. 2. Be unable to undergo percutaneous cardiac catheterisation 3. Have contraindications against magnetic resonance imaging (i.e. claustrophobia, permanent atrial fibrillation). 4. Previous enrolment in the present trial or administration of any study medication within the previous 30 days. Study drug is defined as any material (placebo or drug) dispensed under the provisions of a protocol. 5. Have other severe concurrent illness (e.g., active infection, malignancy). 6. Life expectancy of less than one year. 7. Have a history of alcohol or drug abuse within 3 months of admission or factors jeopardising follow-up. Renal, hepatic, metabolic: 1. Moderate to severe renal impairment (Crea level >1.7 mg/dL or glomerular filtration rate <35 ml/min). 2. Diabetes type 1 patients. 3. Diabetic ketoacidosis. 4. Concomitant medications known to cause hypoglycemia, such as sulfonylureas or insulin. 5. Severe liver dysfunction. Haematologic: 1. Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplatic syndromes (MDS) 2. Severe congenital neutropenia with cytogenetic abnormalities 3. Known allergic reaction vs. Lenograstim Cardiovascular: 1. Acute cardiogenic shock 2. Cardiomyopathy with an ejection fraction below 0.25 (i.e. ischemic or dilated cardiomyopathy resulting in congestive heart failure) 3. Infective endocarditis 4. Factors contraindicating cardiac catheterisation (e.g. severe allergy against iodine, severe thyroid disease) 5. Planned operative revascularisation 6. Prior thrombolysis 7. Left ventricular thrombus 8. Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation). Pulmonary: 1. Acute massive pulmonary infiltrations 2. History of pneumonia in the last 4 weeks Other: 1. Therapy with immunosuppressants, cytostatics, corticoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess myocardial regeneration by Sitagliptin in combination with G-CSF, as measured by change of global myocardial function from baseline to 6 months of follow-up. Analysis of cardiac function consists of evaluation of left ventricular ejection fraction by means of magnetic resonance imaging.;Secondary Objective: - segmental end-diastolic myocardial thickness, segmental systolic wall thickening, regional contractile reserve, end-diastolic and end-systolic volumes, stroke volume, and cardiac output (measured by MRI at rest). - Extent of non-viable myocardium will be monitored from baseline up to 6 months measured by MRI delayed enhancement. - myocardial perfusion at rest up to 6 months as measured by MRI. - major adverse cardiac events (death, myocardial infarction, CABG, or re-intervention) up to 12 months. - safety of treatment of Sitagliptin in combination with G-CSF in CAD patients suffering from MI (adverse events (AEs) up to 12 months). - CD34, CD34/KDR and CD34/CD26 positive cells in PB prior to and 5 days after therapy initiation (assessed only in patients recruited at the site Klinikum Grosshadern). - plasma levels of NT-pro-BNP prior to and 5 and 28 days, and 6 months after therapy initiation - in stent restenosis using angiography 6 months after facultative PCI. ;Primary end point(s): Difference between the left ventricular EF at baseline and after 6 months, both measurements obtained from MRI. | — |
Countries
Germany
Outcome results
None listed