Sitagliptin Plus Granulocyte-colony Stimulating Factor in Acute Myocardial Infarction

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Trial design:

This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: HEINZ NIXDORF-FOUNDATION
• Treatments: Lenograstim; Sitagliptin Phosphate

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) and/or occluded coronary artery

3. Intervention of infarct related artery by PCI/Stenting within 2-24 hours after onset of acute myocardial infarction.

4. have creatinin kinase elevation of more than three times of upper normal level (i.e. 540 U/l) accompanied by a significant elevation of CK-MB isoenzyme and/or Troponin I/T

5. Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.

6. Patients who are further suitable for coronary angiography and angioplasty with stenting of the infarct related artery.

7. Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

8. Give a written informed consent.

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 (e.g. non-MR compatible implants or medical devices)

4. Have conditions that may severely degrade image quality (e.g. severe arrhythmia) or prevents from MR scanning (e.g. claustrophobia)

5. 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.

6. Have other severe concurrent illness (e.g., active infection, malignancy).

7. Life expectancy of less than one year.

8. Have a history of alcohol or drug abuse within 3 months prior to 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.

5. Severe liver dysfunction.

Haematologic:

1. Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplastic 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. Left ventricular thrombus

7. Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation) within 24 hours after admission.

Pulmonary:

1. Acute massive pulmonary infiltrations

2. History of pneumonia in the last 4 weeks

Other:

1. Therapy with immunosuppressants, cytostatics, corticoids.