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Sitagliptin Plus Granulocyte-colony Stimulating Factor in Acute Myocardial Infarction

NCT00650143 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Lenograstim (GRANOCYTE)=GCSF

10 µg/kg/d s.c. for 5 days divided in two dosages per day

DRUG

Sitagliptin (Januvia)

100 mg p.o. per day for 28 days

DRUG

Sodium Chloride (NaCl) 0.9 %

applied s.c. twice a day for 5 days

DRUG

Gelatin

One capsule p.o. per day for 28 days

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Wolfgang M Franz, Prof. Dr. · Clinic of the University of Munich-Grosshadern, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00650143 on ClinicalTrials.gov