Clinical Trials Logo

Clinical Trial Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction


Clinical Trial Description

Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI) with successful revascularization following percutaneous coronary intervention (PCI) and stent implantation.

Primary Objective

• To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo

Secondary Objectives

- To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo as determined by cardiac magnetic resonance imaging (cMRI)

- To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population

- To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset of the study population

Exploratory Objectives

- To examine the effects of dutogliptin in combination with filgrastim on:

- Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels

- Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03486080
Study type Interventional
Source Recardio, Inc.
Contact Roman Schenk, MD
Phone 415 707-0592
Email rs@recardio.eu
Status Not yet recruiting
Phase Phase 2
Start date June 2018
Completion date May 2019

See also
  Status Clinical Trial Phase
Recruiting NCT02669810 - EXpanded CELL ENdocardiac Transplantation (EXCELLENT) Phase 2
Recruiting NCT02915107 - The SORT OUT IX STEMI OCT Trial Phase 4
Completed NCT02896543 - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction N/A
Completed NCT02531165 - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention N/A
Completed NCT02490969 - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 N/A
Withdrawn NCT01901471 - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock Phase 2
Completed NCT02312336 - A Pilot Study of Transcoronary Myocardial Cooling N/A
Recruiting NCT02071342 - Study of ABSORB Stent in Acute Myocardial Infarction N/A
Recruiting NCT02070913 - COOL-AMI EU Case Series Clinical Study
Terminated NCT01972126 - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction N/A
Withdrawn NCT01678339 - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients N/A
Completed NCT01887080 - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program N/A
Completed NCT01216995 - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI) Phase 2
Completed NCT01325116 - Delayed Educational Reminders in Acute Myocardial Infarction (MI) N/A
Completed NCT01673893 - ClearWay Rx Readmission Registry N/A
Completed NCT01627457 - Heart Cycle Prestudy N/A
Completed NCT01244841 - Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI) N/A
Completed NCT00954161 - Bystander Helping Behaviour for Myocardial Infarction Following First Aid Training N/A
Completed NCT01109134 - Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients Phase 3
Completed NCT00755131 - Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction N/A