The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,100
dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.
Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.
Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
Time frame: within 180 days of randomization
Time to cardiovascular death
defined as the time from randomization to the date of cardiovascular death
Time frame: within 180 days of randomization
Worsening heart failure
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
Time frame: within 180 days of randomization
Total symptom score of the Kansas City Cardiomyopathy Questionnaire
Time frame: at 180 days
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