NCT05881382 (HEAL-MI) is a Phase 3 clinical trial of Dutogliptin + Filgrastim in ST Elevation Myocardial Infarction, sponsored by Recardio, Inc..

Who is sponsoring NCT05881382?

NCT05881382 is sponsored by Recardio, Inc..

What drugs are being tested in NCT05881382?

Interventions in NCT05881382: Dutogliptin + Filgrastim, Placebo.

What condition does NCT05881382 study?

NCT05881382 studies ST Elevation Myocardial Infarction.

Is NCT05881382 still recruiting?

NCT05881382 is currently status unknown. Last updated 1 June 2023.

Last reviewed 2023-06-01 · How we verify

NCT05881382: HEAL-MI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 3, Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction

Status unknown Phase 3 Last updated 1 June 2023

What this trial tests

Phase 3 trial testing Dutogliptin + Filgrastim in ST Elevation Myocardial Infarction in 4,100 participants. Status unknown.

Timeline

1 September 2023

Primary endpoint
1 September 2025

1 September 2025

Quick facts

Lead sponsor	Recardio, Inc.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	4,100
Start date	1 September 2023
Primary completion	1 September 2025
Estimated completion	1 September 2025

Drugs / interventions tested

Dutogliptin + Filgrastim — full drug profile →
Placebo

Conditions studied

ST Elevation Myocardial Infarction — all drugs for ST Elevation Myocardial Infarction →

Sponsor

Recardio, Inc. — full company profile →

Who can join

Adults 18 to 85, any sex, with ST Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
Time frame: within 180 days of randomization
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for ST Elevation Myocardial Infarction

Currently open trials in the same condition.

NCT05785897 — STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT · NA · recruiting
NCT06795035 — Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution · recruiting
NCT07058857 — The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocard · NA · recruiting
NCT06465303 — A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEM · Phase 2 · recruiting
NCT06535503 — Clinical Characteristics and Outcomes Among STEMI Patients With Cardiogenic Shock at Abu Dhabi City · recruiting

Other Recardio, Inc. trials

Trials by the same sponsor.

NCT03486080 — Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05881382 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Recardio, Inc.
Last refreshed: 1 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05881382.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing