SAFETY AND EFFICACY OF SITAGLIPTIN PLUS GRANULOCYTE-COLONY STIMULATING FACTOR IN PATIENTS SUFFERING FROM ACUTE MYOCARDIAL INFARCTION - SITAGRAMI-Trial - SITAGRAMI-TRIA

• Conditions: 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)

• Registration Number: EUCTR2007-003941-34-DE
• Lead Sponsor: Vorstand des Klinikums der Universität München - Grosshadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-04
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified