Phase 2B Study in AMI (REC-DUT-002)
REC-DUT-002 is a global multicenter, double-blind, randomized, placebo-controlled trial that will evaluate the safety and initial efficacy of dutogliptin in combination with G-CSF as an adjunct treatment for patients in early recovery following an Acute Myocardial Infarction (AMI).
Status of Study
FDA approved; patient enrolment to start in mid-2018. Approximately 30 hospitals in Europe and in the US will participate.
Study Design
Based on the pre-clinical determination of efficacy, the establishment of safety, tolerability, and pharmacokinetics of dutogliptin in healthy subjects, and the extensive clinical experience with G-CSF for stem cell mobilization, the present study will evaluate dutogliptin and G-CSF in patients who had an AMI and received successful initial treatment with PCI and stent placement. G-CSF will be used to mobilize stem cells from the bone marrow to circulating blood while Dutogliptin will activate stem cell migration and homing from blood to the site of ischemia or injury in the heart. The study will seek primarily to determine safety and the capacity to improve heart function using cardiac MRI for evaluation.
The study is designed as a double-blind, randomized, placebo-controlled trial (Phase 2B).
Patient Population
Patients being considered for participation in this study are those who have had a large myocardial infarction (STEMI) due to coronary artery atherosclerotic disease within the past 36 hours. Specific eligibility criteria are listed in the link below. After completion of screening procedures, patients will be randomized to receive either dutogliptin in combination with G-CSF or placebo.
Information and Contacts
For more information about this clinical study, visit the following link:
https://clinicaltrials.gov/ct2/show/NCT03486080?term=Recardio&rank=2