Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Sitagliptin Plus Granulocyte-colony Stimulating Factor in Acute Myocardial Infarction

Lead Sponsor:

Ludwig-Maximilians - University of Munich

Conditions:

Acute Myocardial Infarction

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief 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 ...

Detailed Description

The trial will be conducted as a multi-centre trial. Secondary objectives of this study are to monitor changes of regional myocardial function, myocardial perfusion and extent of non-viable myocardium...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Be at least 18 years old, male or female
  • 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
  • Intervention of infarct related artery by PCI/Stenting within 2-24 hours after onset of acute myocardial infarction.
  • 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
  • Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.
  • Patients who are further suitable for coronary angiography and angioplasty with stenting of the infarct related artery.
  • Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
  • Give a written informed consent.
  • Exclusion criteria
  • General:
  • Women of childbearing potential, pregnancy or being lactating.
  • Be unable to undergo percutaneous cardiac catheterisation
  • Have contraindications against magnetic resonance imaging (e.g. non-MR compatible implants or medical devices)
  • Have conditions that may severely degrade image quality (e.g. severe arrhythmia) or prevents from MR scanning (e.g. claustrophobia)
  • 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.
  • Have other severe concurrent illness (e.g., active infection, malignancy).
  • Life expectancy of less than one year.
  • Have a history of alcohol or drug abuse within 3 months prior to admission or factors jeopardising follow-up.
  • Renal, hepatic, metabolic:
  • Moderate to severe renal impairment (Crea level \>1.7 mg/dL or glomerular filtration rate \<35 ml/min).
  • Diabetes type 1 patients.
  • Diabetic ketoacidosis.
  • Concomitant medications known to cause hypoglycemia, such as sulfonylureas.
  • Severe liver dysfunction.
  • Haematologic:
  • Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplastic syndromes (MDS)
  • Severe congenital neutropenia with cytogenetic abnormalities
  • Known allergic reaction vs. Lenograstim
  • Cardiovascular:
  • Acute cardiogenic shock
  • Cardiomyopathy with an ejection fraction below 0.25 (i.e. ischemic or dilated cardiomyopathy resulting in congestive heart failure)
  • Infective endocarditis
  • Factors contraindicating cardiac catheterisation (e.g. severe allergy against iodine, severe thyroid disease)
  • Planned operative revascularisation
  • Left ventricular thrombus
  • Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation) within 24 hours after admission.
  • Pulmonary:
  • Acute massive pulmonary infiltrations
  • History of pneumonia in the last 4 weeks
  • Other:
  • 1\. Therapy with immunosuppressants, cytostatics, corticoids.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2013

    Estimated Enrollment :

    174 Patients enrolled

    Trial Details

    Trial ID

    NCT00650143

    Start Date

    March 1 2008

    End Date

    June 1 2013

    Last Update

    August 25 2022

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Clinic of the University of Munich-Grosshadern, Department of Cardiology

    Munich, Germany, 81377